Moderna

On 12/30/2020 I got a pain in the stomach as if someone kicked me and then a taste of medicine like when you chew a aspirin after taste. But it went away 12/31/2020 I felt dizzy around 3:00pm

starting 10 minutes after the vaccine was given my mouth was very briefly tingling, warm wave came over me, my heart starts to race and del lightheaded. they told me to lean back and relax and it went away in less than a minute.

Received shot 12/28/2020 Monday Monday evening started feeling normal side effects By Tuesday morning 12/29/2020 vomiting, severe arm pain, horrible migraine headache, horrible body aches, chills, exhaustion, and eyes burning. By Tuesday night very ill, vomiting uncontrollably, horrible headache, bad enough medication taken to sleep and stop vomiting (phenagren). By Wednesday skin hurt so bad couldn't touch or be touched....shower was miserable. Continued vomiting and lips started to swell. Started taking benedryl. Lips swollen. So tired and body aches horrible. Vomiting continued...no food eaten since Monday. Call urgent care about lips and symptoms, they said to take benedryl and continue to monitor if things worsen go to hospital. Vomiting continued into late Thursday night. Unable to eat normally now, stomach very very sensitive and nauseated. Extremely tired and headaches continue. Fearful to get booster. Been sick for 7 days and still not well.

?Moderna COVID- 19 Vaccine EUA? After 15 minute monitoring time, patient complained of metallic taste in mouth. She described it as similar to "the taste you get after a saline flush".

I got the shot, didn?t feel it at all so it went good. I went to the bathroom and went pee and got my arm back in my long sleeve shirt under my scrub top. I wasn?t anxious about getting the vaccine. Then I went to sit down and be monitored. After about another minute I felt very weird like a warm feeling going all over my body. I started pulling my mask away from my face to get a deep breath. Then I broke out in a sweat from head to toe. I think I became pale (I apparently didn?t look good). I started feeling more ?weird? as I had never felt this way before and I stood up to walk because the nurse there wanted me upstairs near the ED but I was weak so I sat down and had tunnel vision. After that it?s a bit of a blur. After I stopped sweating I got very cold and shaky but vitals were ok. It scared me because I have never had a reaction before to a vaccine.

I took the Moderna Covid vaccine on 12-28-2020 at 1420. After getting the shot, I had a metallic taste in my mouth and drank some water then waited 20 mins. When I left to go back to my department, I started getting dizzy and coughing. I sat down in my department and could not stop coughing so I went to the ER department. My eyes were swollen, I had a rash from my arms and legs all the way down my body. I had hives on my face and my eyes were swollen. I was coughing and wheezing. the ER RN started an IV and I was given steroids, diphenhydramine, ondansetron and IV fluids. I was also given some cough medicine. I was monitored for a few hours and before I left - they gave me hydroxyzine for the hives and itching. The PA also ordered meds for me to take at home. - per patient report

Patient presented to receive COVID-19 vaccine, received vaccine at approximately 10 am. Patient waited 15 minutes for observation and left observation area without complaining of any sx. Patient returned a few minutes after reporting tongue tingling which eventually got to her lips. . No difficulty breathing or any other sx. No history of allergies. NP/RN administered PO Benadryl 25 mg. As of report of this iReport no additional symptoms or intervention needed. Last vitals: 131/83 75spo2. BP higher than usual per patient, sp02 normal.

Mild itching and tongue tingling at tip. Vital Signs 0746 - BP 112/79, HR 74, RR 18, Temp 98.4, SPO2 100% Vital Signs 0812 - BP 113/74, HR 78, RR 18, Temp 97.2, SPO2 99% Benadryl administered 0749 by, RN

pain, ache behind his right eye, that is still there fuzzy vision that lasted for 30 minutes warmth on top of head and around his ear

overwhelmingly tired exhausted sever fatigue left arm hurts extremely bad by shoulder severe dryness in mouth, almost hard to swallow severe nausea headache

Pain at injection site that persisted followed by numbness and tingling down medial aspect of arm for approximately 24 hours after the injection, upper extremity and neck ache, headache with associated eye pain, fatigue

Right jaw pain, similar to what TMJ would be like, although I've never had TMJ and there's low stress in my life. Pain not relieved by Motrin/NSAIDs, constant 4/10, dull, and interferes with ability to chew.

0625-Employee began to have elevated heartrate, heart pounding in her chest. Color pale. VS-HR-157, B/P-135/105. O2 sats-100% 0630-Ambulated to ED room. HR-148, B/P-150/83, O2sats-100%. Drank apple juice and ate a cracker. Experiencing dizziness, chills and heart racing. 0640-Hr-105-110, B/P-113/71, O2 sats-100%. Feeling better, shaking incontrollable chills. 0700-HR-104, B/P-121/79, O2 sats-100%. Spoke with ED physician-observe for 1 hour and reevaluate. Denies swelling, itching or difficulty breathing. Her mouth is very dry. Tolerating fluids without issues. 0715-HR-97, B/P-118/70, O2 sats-100%. Continues to experience waves of dizziness and chills. Episodes are spacing out further and not lasting as long. 0730-HR-90's, B/P118/70, O2 sats-100%. Tolerated ambulating to bathroom without problems. States just not feeling herself. Has opted to go to the clinic for evaluation. Assisted to clinic-tolerated ambulating without problems.

First day out had pain behind right ear, thought it was muscle but went into my head, lasted 4-5 days now I have severe tenitus in right ear and my head has not felt right since. Like my hearing hoes in and out. I thought it would go away but it?s been two weeks. My head feels cloudy and my right eye feels messed up like blurry. No other injury have occurred. This all started a day after the vaccine.

RN received her first dose of the Moderna Covid Vaccine on 1/6/2021 at approximately 0615 at hospital. Within 5-10 minutes patient noted that her heart was racing and pounding in her chest. Hospital RN went and assessed patient- color pale, heart pounding. HR-157, B/P-135/105, O2 sats-100%. 0630-Ambulated with patient to ED area and sitting in recliner. C/O of dizziness, chills and heart continues to race. HR-148, B/P-150/83, O2 sat-100%. Patient given warm blankets. Patient had not eaten yet this morning so was given apple juice and cracker. Tolerated well. Patient states her mouth is tingly and is very dry. Drinking fluids with out problem. 0640-Feeling better, chills- given warm blankets. HR-105-110, B/P-113/71, O2 sats-100%. 0700-Spoke with ED physician-plan to observe for 1 hour if no improvement will evaluate further in ED. Patient denies any swelling, itching, difficulty breathing. HR-104, B/P-121/79, O2 sats-100%. 0715-Patient is experiencing waves of chills, dizziness and then feeling better. HR-97, B/P-118/78, O2 sats-100%. 0730-Patient continues to feel better but has waves of dizziness and chills. HR-90's, B/P-118/70, O2 sat-100%. Patient was able to tolerate walking to BR without problems. Patient has opted to go the Health Clinic for further evaluation. Family is coming to pick up Patient following this. Patient hasw been instructed to register for V-safe, complete the Covid Intake form and call the Covid Hotline. Patient tolerated walking to the clinic without issue.

at 1210 patient received the moderna vaccination o. 5ml in her left arm she went to sit down and at 1218 she stated she doesn't feel right she got all panicky and restless. we placed a pulse ox on her her HR was high 160's oxygenation 100% BP 158/88 she said her heart felt like it was racing and she was all hot and her lips were tingly.... another RN present said her lips looked a little blue at one point rapid response called . Patient stated she felt a little better, heart rate was in 120's rapid response team decided to send her to the ER for observation

Low grade fever with chills, headache, neck stiffness, pain behind eyes, sensitive skin (from fever), muscle aches and cramping, severe fatigue. Pain in arm and stiffness. Started 5 hours post injection and continued to intensify despite tylenol over the course of 36 hours. After 36 hours the symptoms began to subside.

About 5 min after the vax I was at the recovery/triage at the vaccine place and I started to get tingling and numbness on the right side of my tongue, so I did not actually reported as a concern but after my 15 min observation I left but then the numbness and tingliness got worse in my tongue and now lower lip and then I decided to return to the vaccine area to report my symptoms and they brought me over and took my vitals and they were stable BP/HR were normal and the numbness and tingling did not get any worse but because of the reaction they gave me 25mg of oral Benadryl probably around 40 min after the vaccine they kept monitoring me for abot 2 hours but my vitals remained very stable and the numbness and tingling have resolved. My tongue was still numb but not getting any worse so i felt it was ok to leave. I decided to go home after those 2 hours and i took 10 min of zyrtec and about 5 hours later i still had a little numbness and tingling on the right side of the tongue but the rest of the tongue and lip had resolvedf. Had fatigue and myalgia for the rest of the day.

Fatigue, confusion including disorientation and perceptual disturbances that fluctuated throughout the day. Two episodes of orthostasis and severe tinnitus lasting about 5 minutes each.

Same day - blurred vision that went away shortly after experiencing. Headache, tired, very swollen at site of injection, diarrhea, chills, temp of 101.

Tachycardia "scratchy throat, fuzzy feeling tongue neck beginning to swell" Narrative: monitored for 4 hours and discharged to home with epi pen,

Every morning, following the vaccination, I woke up with a moderate headache. Tuesday through Thursday I was able to control the headaches with 600 mg of Ibuprofen. But Friday I had a migraine with light sensitivity and it was not relieved by using Ibuprofen or Aleve. It finally spontaneously resolved at around 1330. I've been otherwise fine.

At exact moment of injection, I had a metallic taste in my mouth. Immediately following injection, I felt lip tingling and numbness. I visited the ambulance on site, no treatment necessary per EMTs because I was without rash or lip/tongue swelling.

pt reports received Vaccine on 1/7/21. she did have a biopsy on scalp 1/6/21 for possible basal cell. Woke up 1/10/21 with some swelling noted around both eyes and forehead. She has no other symptoms. She did take some OTC benadryl last night before bed and woke up this am with no change in swelling noted. she was unsure related to vaccine or related to the scalp biopsy.

approximately 10 minutes after Covid vaccine the patient was starting to have right sided facial tingling then she started to have tingling in her throat. I sat with her and she had progressive tingling, worsening throat tightness and some facial swelling under her eye. We then moved her to a room and laid her down. I discussed the use of the Epipen and a dose was given at approximately 400PM. We also called 911 at that time. Vitals were taken and EMS arrived and by the time they were taking her away her symptoms were improving.

Patient noticed immediate warmth traveling through arm and radiating up neck and face. She also tasted a metallic sensation. After 15 minutes she developed itching on her face and neck with hives developing. She felt a sensation of a "band around her neck" and described a sensation of something "sitting on the band". At 10:15 we called EMS, administered an Epi Pen. EMS service administered Zofran for nausea that occurred when she tried to sit up after lying flat. They also gave Benadryl. She was transported the ER.

-Pt received COVID19 vaccine (Moderna) at MDLS on 1/8/2021 at 9:51 PM. -Pt was observed for the recommended 15 minutes but then came back at 2:13PM with a little rash on her face and chest. -Denies headache, shortness of breath, difficulty breathing, chest pain, dizziness, numbness/tingling, N/V, rash anywhere else on her body, difficulty swallowing, itchy/sore throat, itchy/watery eyes, congestion. -Vitals were stable (see vitals). -Pt was observed for 30 min & did not have worsening of rash or other symptoms. -Discharged after 30 min.

6 hours after vaccine, developed rash around waist line, next morning woke up to itchy rash on back of head and neck, took Claritin. Next day, developing more small rashes, called Kaiser and was told to take Benadryl. Next morning woke up with more hives and had to go to ER because throat felt like it was closing. Given epipen, prednisone, prevacid . Sent home and symptoms worsened again so gave herself epipen before heading back to the ER.

Redness, swelling and severe itching to injection site. Numbness and tingling to mouth,lips, gums and toung and severe headache 8 days after injection was given.

Beginning feeling tingle on the tonged, 10-20 sec. Soreness at the inj site. 2hrs later tired. Little nausea. 1/14/21 bad nausea, cold hot sweats, flu like symptoms. Nasal congestion and fatigue. Symptoms are trickling in not all at once.

5 days after vaccination, I woke up to two swollen eyelids and some swelling under the eye. with itchy hands, fingers and palms and elbows. No visible insect/spider bites, not itchy, no moisture or discomfort with both eyes. No known changes in diet, only change that occurred was new use of an Eyeshadow/makeup place on both eyelids. Swelling in eyes lasted 3 days with gradual decrease in swelling, itchy palms, hands and elbows persistent for those three days, Benadryl helped ease itch.

The patient received the first dose of Moderna Covid vaccine at their place of work on 12/22. They had no complaints after initial vaccination. On the morning of 12/23 the patient experienced light headedness, diaphoresis, tunnel vision, low blood pressure of unspecified and what could be described as a near-syncopal event. Patient states they did not lose consciousness or fall during this event. Patient then called EMS and was taken to ED by which time symptoms had mostly resolved. Still had complaints of general fatigue and arm pain. Patient received no medications and was supervised for 2-4 hours before being discharged. Of note patient previously had COVID in June and was hospitalized for 6 days, the patients pulmonary function remained stable during that admission.

This facility staff member received her first dose of the MODERNA COVID-19 vaccine (Lot037K20A/EXP 6/22/21) at clinic at approximately 9:15AM on 1/14/21. She initially answered "no" to any allergies on the VAR but revealed to the pharmacist reviewing the VAR that she had experienced an allergy to food and contrast dye that required an epi-pen and hospital attention. She did not offer additional details and explained that she had tolerated other shots (including the 2020 flu shot) without incident. I advised patient to remain for a 30 minute monitoring period post-vaccination due to history of allergic reaction. Patient presented with some anxiety before the shot and immediately started to complain of feeling "sick" and said she was having trouble breathing due to chest pressure. We advised patient to remove her mask and provided her with water and a trash can though no vomiting occurred. After 15-20 minutes, patient still complained of chest pressure and difficulty breathing. When asked if she was experiencing any itchiness or throat swelling, patient said she did feel some throat swelling so she was given 25MG of Benadryl. After an additional 15 minutes, patient's condition seemed unchanged (not worsening, not improving) so the facility's nursing team was called to evaluate patient. Patient said she was still experiencing difficulty breathing and throat swelling so nursing advised use of EPI-PEN and patient consented. I administered a dose of 0.3MG (LOT0FM4066/EXP 02/2022) to the right lateral thigh and nurse called for EMS. Immediately after injection, patient's eyes fluttered and she seemed to be on the verge of fainting. Nursing checked her oxygen saturation which was 100%. Patient reported no improvement after 5 minutes so another EPI-PEN 0.3MG was administered to the left lateral thigh. Nursing also gave the patient 81MG chewable aspirin due to the patient experiencing a stroke last month. EMS arrived a few minutes after the second EPI-PEN dose and patient was transported to the hospital for evaluation. Facility reported that patient went home that afternoon but did not provide details. Based on my assessment of patient's symptoms and behavior, I feel it is likely that she experienced either an acute panic attack or anaphylaxis due to vaccine administration. I called the patient today (the day after the incident) and she confirms that she received treatment for an anaphylactic reaction to the Moderna COVID shot and is doing well without any lasting adverse effects.

perioral, numbness/tingling Employee reports peri-oral numbness/tingling 15 mins after vaccine administration. Employee immediately escorted to ED for airway evaluation. On arrival to ED, all VSS. No airway compromise. Given 50mg PO benadryl and 10mg PO zyrtec and then d/c'd home.

Patient began to feel numbness and tingling in fingers and toes 15 minutes after injection. Was given water and support. 30 minutes after injection stated her throat was numb, her tongue was tingling and she had a very dry mouth. BP was slightly elevated at 133/100. Pt seemed very anxious and was given emotional support. Epi was on standby, discussed course with MD and was advised to wait giving epi unless symptoms worsened. 45 mins after injection symptoms were worsening. Pt able to breath but mouth and throat tingling was worsening. Called 911 to provide observation in case symptoms worsened. Pt agreeable to being observed in ED.

1000 - Patient c/o headache. States she is a diabetic. Took meds for diabetes this morning and ate breakfast. States she experiences headaches when blood sugar out of control. States she feels dry. Gave water. Swallowing without difficulty. Has a glucometer patch on left upper arm and took out wire free glucometer and scanned arm. Glucose is 161. 1002 - experiencing blurred vision. States headache aching in temple area across forehead. Denies dizziness. Stood and ambulated independently to private observation area without difficulty. 1004 - EMT at site in attendance. BP 144/98; HR 100; )2 sat 99% on room air. No SOB noted. States she took her BP meds this morning, but not her Lasix. States that is unusually high BP for her. EMT and nurse recommended transport. Patient agrees. States she drove to vaccination site alone and will leave car in lot. States she has a 2009 Honda Accord 2 door coupe with disabled woman veteran on her license plate with tags reading VD....... (can't recall numbers). Assured security will be notified so that vehicle will not be towed if left overnight. Wants to go to THR Southwest Fort Worth ED. 1012 - having difficulty focusing eyes. Headache remains. PERL; 3-4 cm bilaterally. Equal hand grasps, no drift. speech clear 1014 - BP 136/92; HR 97; O2 99% on r/a 1016 MedStar activated per EMT in attendance. Patient states H/A pain is 8/10 aching. Still has blurred vision, c/o dry mouth. Continues to drink water without difficulty swallowing. Now describes having general tingling throughout upper body, along both arms. Denies itching. 1036 - States she feels drowsy, remains oriented x 3. States H/A now 9/a0 1044 - MedStar arrived and patient immediate ly placed on stretcher and patient transported to hospital. Patient speaking to paramedics as leaving building.

Update: Already made one report on January 13th describing how right hand and upper lip was numb. Right hand numbness lasted 4 hours then returned to normal. Upper lip numbness lasted 10+ hours and resolved sometime during that night when I was sleeping. On 14th when woke up (numbness gone) but had about an inch redness around injection site with a 7mm× 7mm lump under skin where injection given sore to touch. On 15th site reaction still there and felt low on energy. Today 16th then redness seems to be a bit better and taking on more darkish hue (maybe turning into bruise?) And lump feels slightly smaller and not as sore. So site reaction might be on the way towards healing. However today I have been fatigued and drained feeling, low on energy. ( Dr notified of numbness post injection, and pic of arm via online portal. (No reply from Dr as of this date). Seem to be on mend other than increasing fatigue, low on energy.

About 25 minutes after my vaccine was administered, the left side of my face went numb. My left fingers were tingling and I had a hive-like rash on my neck and left side of my face. I also had a metallic taste in my mouth. This occurred in my drive home. Upon returning home around 20 minutes post reaction, I took 1 Benadryl and started feeling improvement about 30 minutes after I took the Benadryl. I didn?t feel 100% normal until the next morning.

vaccine administered 1/15/21, 10:45 am; symptoms started at 9:45pm 1/18/21, and first symptoms were extreme dry mouth sinus pressure, severe headache, nasal discharge, feeling cold. Symptoms worsened and peaked around 3pm 1/19/21 when I had a fever of 99.1 degrees F, some wheezing, dry cough, body aches and pains, sinus pain and congestion.

Within an hour, began itching, body aches, fatigue. 1/4/20 had full menstrual cycle with cramps (have not had one in 12 years due to mirena) 1/9/20 wide spread hives, rash, swelling of ears, tongue, nose. Began steroids. 1/15/20 swelling and rash began again, went to ER. Raised steroids. High emotions, brain fog, confusion.

Had Moderna 1st shot on Jan 7. Eye infection that night and the next day. Then, Saturday the 16th, a tickle in my chest.. soon produced a dry cough in relief/response to the tickle. Next day, I was hoarse (Sunday the 17th). Still hoarse. Sore throat off and on. Headache. Body aches. Incredible arthritis-like ache at the tops of my shoulders, upper back, and neck. Runny nose. Spitting mucous - was clear, now some thick solid white. Chest pain in the middle that comes and goes. Chest pain on left center side - it feels like in the area of my heart. Ache in my lower left side. Today, aching in my jaws mostly left side, but both. Ache on upper right front (lung area?). INCREDIBLY tired. It's so hard to stay awake.

Employee states swelling to tongue and throat, hives, itching, and now bruises easily. She went to emergency room where she was given Benadryl, Medrol dosepak, and Pepcid. The only remaining symptom is bruising easily.

Approximately 3 days after my injection I began experience severe tremors Ib bilateral arms, bilateral legs, head, and vocal cord tremors as well as blurry vision and memory impairment. Unfortunately, the symptoms don't seem to be improving. My MD prescribed metoprolol, which I will begin today.

Coppery taste and itchiness/redness on face and torso. No hives or rash. Happened about 75-90 minutes after injection. Took Benadryl after speaking with RN at office.

I was vaccinated on 12-30 after 4 pm. By 3:30 on 12-31 my neck quickly swelled up, my throat becoming sore, glands swollen, headache, and fatigue were my first symptoms. An unusual symptom occurred from day 2-6. My facial skin did not hurt unless I applied pressure. When I applied pressure it felt bruised and highly sensitive but didn't hurt unless pressure was applied. I also developed a small sore along my gum line on the bottom right front of my mouth. Both of these symptoms disappeared after day 6. 7-8 days after receiving the vaccine my neck, jaw and shoulders became extremely stiff, including a runny nose. This symptom has persisted and is the worst of all symptoms (jaw and neck stiffness and sore throat). On day 12 in addition to the ongoing sore throat, and stiffness in my neck and jaw I developed white spots on my right tonsil. 3 days after the white spots disappeared, but the red sore throat is current. On day 20, I developed 2 more sores on the right side of my mouth. One on the bottom gum line and one on the top right gum line (this feels like a canker sore). Today I have a slight earache in my right ear. NOTE: I tested positive to COVID June 2020. I ended up taking 1 month off work due to persistent symptoms. I still cannot properly smell and taste, and I can smell water. Occasionally, the brain fog from COVID comes up but that is more rare.

1-5: fever, chills, aches,fatigue. Started tylenol/ibuprofen 1-6: facial and throat swelling, continued side effects. Started benadryl. Continued through 1-7 with some improvement in swelling and general side effects. 1-8: swelling and numbness with droop to left eye and numbness to lips. IC visit. Received steroid injection and started pepcid and allegra in addition to benadryl. 1-9: swelling and most general side effects resolved. Left eye numbness/droop and numb lips still present. 1-10 : Droop resolved, numbness remained. 1-12: Numbness resolved.

I waited the 15 min at the clinic and felt okay. As I got a few minutes down the road (at about 4:00) my lips began to feel tingly this then spread to my teeth and face. I could feel my throat begin to tighten. At that point I call the clinic and they suggested I go to ER to get looked at. Got to ER and Tingling and numbness continued, throat had started to loosen up some but felt thick and heavy. I also had a headache that was more like pressure all over then stabbing and my teeth and jaw ached. Doctor saw me between 4:30 and 5 sometime gave me diphenhydrAMINE 50 mg by mouth, famotidine 20 mg by mouth and dexamethasone 10 mg by mouth. By 5:45 symptoms were dissipating and I started to feel more normal. By 6:45 I felt much better (just very fatigued from the medications and slight headache still), and was discharged from E.R. sometime a little after 7. Through the night I had headache and hot flashes. Next morning some face swelling and tongue swelling still as well as tightness in throat (mild) continue to take Benadryl as suggested by E.R. doctor.

Tongue tingling and throbbing Immediate headache Hives on back of neck at hairline and a small patch on upper chest that persisted for weeks following initial vaccine. First day hive free was January 19th.

Rash, hives, itching, tingly lips, heat, nausea. Benadryl and claritin. Hives and tingly lips went down after 1hr. Itching lasted 5 days.

After approximately 5 minutes after the vaccination, the patient report swelling on the throat, heavy tongue, and some itching. At 5:30 pm 50 mg of oral diphenhydramine were given and after that the swelling of the tongue worsen an at 5:33pm an Epinephrine auto-injector of 0.3 mg was administered on the thigh. After that patient was transported to the nearest hospital and the family of the patient was contacted.

12-24 hours post vaccine :Tongue Swelling and Tongue ulceration , no treatment, non-emergent. Swelling resolved on 1/20/21. 12/21/21: Ulceration still present. No treatment.

1.6.2021 AT 945 PATIENT REPORTED "FEELING HOT" AND "TONGUE TINGLING" PATIENT REFUSED EPINEPHRINE AND BENADRYL. PATIENT ACCEPTED ICE PACKS AND WAS TAKEN TO MEDICAL CENTER BY EMS.

Angioedema- swelling to left upper lip, sensation of tightness in throat, no visible edema of tongue or posterior pharynx, no difficulty breathing, wheezing, or stridor

12:52 pm - face/mouth area feels itchy; heart palpitations occur; 12:56 pm - face starts getting blotchy with hive-type mark near mouth; 1 p.m. - body starts feeling itchy allover; Around 1:20 pm the mouth hive seems to have gone away and the itchy is less bothersome. By the afternoon, everything seems to have subsided. Arm is very sore the next morning.

Full body itching including eyes and throat, blurry vision, headache, fatigue, dizziness, 1-101 fever

onset of chest pressure, tachycardia within 10 minute. hives, swelling of lips and upper extremities, shortness of breath, systemic itching, sore throat and change in voice occurred 20 minutes post vaccination. epi-pen administered at onset of hives, etc. taken to ED and given more epinephrine, IV solu-medrol and diphenhydramine. monitored for a few hours and then discharged. 5 day course of prednisone prescribed.

One week post vaccination, developed angioedema of left eye, experienced hives over entire body, tongue itching, scratchy throat, tachycardia

Went out to car around 25 min after with only mild throat discomfort. Shortly after, was having difficulty swallowing, felt dizzy & face swelling. Took quick release (dissolve under tongue) prednisolone 20 mg (have for peanut allergy). Symptoms didn't initially improve, used albuetrol inhaler and returned to hospital. Swelling symptoms started feeling better. Blood pressure when first checked was very high, still at 170/118 at 21:54. Sent to ED. Wheezing and constant throat clearing in ED, used inhaler again & symptoms improved. BP still high for me at 138/80 at 21:54 with patchy confluent erythema over anterior chest that blanches, non-pruritic & 3-4 hives on abdomen. Given Benadryl 50 mg, famotidine 50 mg & dexamethasone 10 mg at 22:22. At 23:09, chest rash resolved, but pruritis & mild urticaria to back and arms. At 23:41, urticartia resolved & discharged. After second dose of Decadron was delayed the following day, itchy hives returned on chest, stomach, back and left shoulder. Same occurred on the 3rd day, along with wheezing (resolved by other meds & inhaler) and more steroids were prescribed. This resolved the remaining symptoms.

1510 - patient c/o tongue tingling and numbness. Also feels like back of throat has something stuck on it. Taken via w/c to private observation. Gave patient water. States she has difficulty swallowing it. O2 99%; HR 110; RR 16: BP 124/95. EMT on site in attendance. Per assessment with pen light, throat is not swollen or red. Patient states she feels like it is much lower and points to tracheal area. Lungs auscultated, BBS CTA, no wheezing, no stridor. Offered patient 25 mg Benadryl. Pt. declined. States she drove herself and that it will make her too drowsy. 1525 HR 101; O2 99%, BP 123/106; recommended ambulance for further eval/transport.. Patient refused. States she will call her husband to come and drive her home. States that the tongue is feeling swollen now. 1530 - Benadryl 25 mg given IM Lt. Deltoid per EMT. 1531 - BP 160/100; HR 104; O2 98% 1535 - Dr. present 1537, Thickness in throat decreasing as per stated by patient. Lungs assessed per Dr. , Lungs CTA, no wheezing, no stridor. Per assessment Dr. , throat clear without swelling noted. Advised per Dr. to avoid second dose and to take additional benadryl PO once home. Waiting for husband to arrive. 1555 - B P 116/96; HR 96; O2 99% 1559 - Husband arrived. Patient states she feels fine and ambulated with husband to personal vehicle. Gait steady. States she will f/u with physician

immediate metallic taste in back of mouth ( reminded her of iron supplements she takes). The next day felt pressure in chest like indigestion, but she says that happens frequently.

30 minutes after the shot, the roof of my mouth and back of mu throat went numb. Only lasted 15-20 minutes. Extreme fatigue and headache. Fever and epistaxis

Went to the ER for mild swelling of the mouth and throat, also had chills, body aches, fatigue, muscles aches.

30 minutes after getting vaccine she reported lips tingling, felt hot all over body, became diaphoretic. Was given Benadryl 25 mg PO at 1126. By 1137, pt reported her lips stopped tingling and her skin was warm and dry. Was monitored for another 30 minutes in the lobby, then sent home with Benadryl.

ADVERSE EVENT: NAUSEA, VOMITING, HEADACHE, SWOLLEN TONGUE TREATMENT: BENADRYL ADMINISTERED IM AND OBSERVATION OUTCOME: RELEASED AFTER 1 HOUR OF OBSERVATION

Saw flashing lights withing 5 minutes of receiving vaccine. Visual disturbances lasted about 10-15 minutes. Pt also experienced chills/shakes approximately 15 minutes post vaccination.

I started noticing vision changes a few days after receiving the vaccine and went to the eye doctor. I was told I had white blood cells in my aqueous fluid which appeared to be an inflammatory response to something. The official diagnosis was uvetis. There was not really any explanation for what could cause this. I do not have any history of eye problems or autoimmune conditions. I was put on steroid drops and dilating drops. I have had two follow up appointments and have been improving. I also noted a large lump and redness at the sight of injection one week post shot. That has since cleared.

Numbness and tingling in lips and oropharynx progressing to face; flushing and redness on chest, itching of hands, eyes, neck; nausea and stomach cramping all onset approx 30-40 minutes after vaccine. Treated in the emergency department w/ famotidine 50mg, solumedrol 125 mg, 1L NS. Noted frequent multifocal PVCs and runs of ventricular bigeminy during Emergency Dept evaluation and ongoing intermittent facial tingling and itching. Admitted for overnight observation.

Tingling in limbs, numbness and tingling in lips, tongue and throat thickening, nausea, trouble speaking and swallowing. I was given 25mgs Benadryl by mouth and taken directly to ER. In the ER I was given another 25mg Benadryl by mouth, hooked up to BP monitor, heart monitor and pulse ox. After seeing the doctor on duty I was given an injection of a steroid and Vistaril and 2 Pepcid by mouth. The symptoms began to subside and I was released approximately 2hrs later with prescriptions for Prednisone, Pepcid, Epi-pen and told to take 50mg Benadryl every 6 hrs for 3 days. I was to return immediately if symptoms reoccurred.

210 am woke up hot. Walked downstairs had ringing in my ear and saw stars, held the wall almost passed out. Began profusely sweating drenching my clothes. Nausea began. Went back upstairs sat on my bathroom floor due to nausea/ dry heave. All of a sudden SEVERE abdominal pain began 10/10. Cried for my husband. Dripping sweat gave me a cold rag and foam large diarrhea began. Still 10/10 pain in abdomen. Felt like my lower abdomen was getting ripped out. About 45 minutes or so later still 10/10 wanted to go to ER. I could not stand. If I stood my legs and body felt like I wanted to curl in a ball on the floor. He called an ambulance. I was pale as a ghost, no fever, normal vital signs. Went into full reynauds flare from body stress. Ambulance was unable to get oxygen sat and glucose at the time due to flare. Arrived at the ER labs drawn. WBC 10.9 and Glucose 194. I am not or never have been diabetic. Vaccine related. Like a lightswitch all symptoms stopped except sweating hot and cold spells, sore arm and drowsiness. Discharged at 6am

The patient received the 1st dose of Moderna vaccine. She waited 20 minutes for observation without any symptoms. She left and began to drive home in her car when she felt her tongue begin to swell. She returned to the vaccine clinic observation area and was transferred to the ED. Her overall symptoms included tongue swelling, throat irriation, oral and facial swelling, lightheadedness, shortness of breath, wheezing, hypertension (170/118; HR=83), urticaria over chest wall. The patient had self-administered oral prednisone prior to ED transfer. Was further treated with diphenhydramine, famotidine, and dexamethasone. Discharged to home after 3 hours. Follow-up notes report symptoms resolved by 2 days post-discharge.

Sore arm at site immediately after injection, moderate abnormal fatigue approximately 2 hours before bedtime, right side neck pain, right side wrist pain. Following day: all joints hurt, neck lymph swollen, mild raspy breathing chest congestion, no appetite, fatigue, malaise, sensitivity to sounds, sensitivity to cold. Uncomfortable. Don't want to move. Just want to lie down.

IMMEDIATE: dizziness, light-headedness, shortness of breath, jaw clenched shut (lasted about 30 seconds) FOUR HOURS AFTER VACCINATION: muscle weakness, confusion, brain fog (All of these symptoms are on-going.) 33 HOURS AFTER VACCINATION: in addition to previously mentioned symptoms, fever, chills, extreme muscle fatigue, headache, jaw soreness

With in 5 mins of getting my shot I started to get sweaty and my heart starting getting bad palpitations. I could feel myself get super flush, I could feel my whole body warming. I had a hard time swallowing and my tongue burned and felt swollen. My throat would just get super tight. Each episode lasted under a minute This happened on and off it for about 30 minutes. Each time it happened it was not as bad as the time prior. I was dizzy when I tried to stand up and I sat and was monitored for an hour. They administered Benadryl. I have some edema on my upper chest when I got home. I was super tired too. The next day still the edema and I have a sore throat . I explained the best I could to the pharmacist when it was happening . I refused to get EMT because it was not constant and it was getting less intense each time.

mild lightheadedness 20 minutes after vaccine. Starting on the day following the vaccine- parasthesias in the right and left hands, right occipital region of head. 2 days after vaccine developed generalized muscle fasciculations and muscle fatigue which progressed to weakness (diffuse, worse in arms). Tinnitus developed in the first week after vaccine. Symptoms have persisted now 5 weeks out from vaccination (parasthesias have improved, muscle symptoms and tinnitus continue).

Patient was vaccinated at 12:27PM, presented to the post-vaccination observation area and informed staff that she had prior reactions to the first dose. 12:38PM ? Patient started to experience flushing and warmth on neck and ears. Slight redness noted on area. 12:40PM ? Patient reported visual changes. Stated: ?Everything looks brighter than normal. I constantly have to readjust my focus.? Benadryl 12.5mg chewable offered. Patient declined and stated that she gets drowsy on medication and had taken two (2) the night before vaccination. 12:50PM ? Patient report itching on both sides of torso, vital signs taken BP- 119/76 SPO2-99% HR-68 1:00PM ? Patient reported itching has started on head, Benadryl offered and declined. Patient was offered to take Benadryl to have on hand. Patient agreed and stated she would take one once she is halfway home. 1:05PM ? Patient reported some itching in between thighs, declined to have it looked at in bathroom. Instructed patient to take Benadryl on the way home ? patient agreed. Educated patient to stay hydrated, take a Motrin/Tylenol if expected signs and symptoms are experienced. Instructed patient to check in with nurse (Contact # given) once she arrives home. 1:28PM ? Patient contacted nurse via text, stated that she was home. Still feeling flushed and was going to lay down.

Within 30 seconds had metallic taste in my mouth. Approximately 1hr 15 minutes later I began to experience swelling of the tongue, scratchy throat, headache, heart palpitations and nausea, which progressed through the evening. Benedryl was taken PO at approximately 2005. At HS (approx. 2230) tongue was still swollen, though not grossly. In the morning my tongue was slightly swollen, but improved. All other symptoms persisted for 3-4 days.

About 1 hour after vaccine: Strange taste in mouth, strange feeling on tongue (not swollen) About 24 hours after vaccine: itchy face, headache, stiff neck and back, fatigue, low fever After 40 hours: fever gone (highest was 99.8), stiff neck and back improving, fatigue improving, face is still itchy.

Approximately 4 hours after receiving the vaccine, she experienced blurry vision, stated it was hard to focus and felt some generalized numbness. RN at her side, checked BP 156/94, pulse 90. Patient awake, alert and oriented. RN called 911. EMS arrived approximately 10 minutes after the call. Patient taken to Emergency Department for evaluation.

states had 2nd covid vaccine yesterday (2/3/21), had cosmetic lip filler in November 2020. Noted/felt lower L lip swelling this am which appears sl better, then noticed upper L lip swelling (nothing on R). No itching or pain. No resp or thrt sx. Does have localized injection site redness and swelling, ? sl generalized body aches, otherwise no sx. Takes Zyrtec daily for other allergies. Did not have any lip reaction with 1st vaccine. 15 yo child at home does not notice any difference in her appearance. did do google search and there was reference to others who had lip filler having similar reaction s/p covid vaccine

Numb lips about 45min later, lasted about an hour. injection site pain and swelling late afternoon, night and next day. Upset stomach/naseua throughout night and morning.

Top lip tingling, swelling, itching all over body, rapid heart rate, throat felt "thick" had to keep clearing throat or drinking

On 02/03 I got red bumps on the injection site. On 02/04 the injection site became completely red and itchy, I have also noticed a change in my vision.

After injection waited in medical observation due to medical conditions, developed Severe Headache, blurry vision, & Increased Blood Pressure.

Started having neck pain 3 days after first dose. The pain sometimes hurts in my ear and into my head. It hurts to move my head or touch my neck. This is the same side of my body I received the shot. It hurts to lay on that side because just the pillow touching it hurts. No other symptoms except soreness at the site of the shot within 24 hours which subsided within 48 hours. I have been taking tylonal today which seems to help.

tongue started feeling numb about 3-5 minutes after vx the slowly started spreading to my throat and lips started to feel a little swollen nurse on site gave me the emp pen and a shot of benadryl and called the ambulance. I started feeling better right after the emp pen injection

Received vaccine on 12/28/2020. started having muscle aches, ear pain, chest congestion, cough, fatigue, nasal drainage, HA, nausea and vomiting, chills on 12/29/20. Went to urgent care on 1/1/21 and diagnosed with viral upper respiratory tract infection.

Chills on day 1 @ 20:00pm Day 2 (2/6/21)- Headache, Body ache, Left eye swelling (ongoing for 2 days)-Treated with tylenol and Motrin, Xyzal taken daily. Day 3 (2/7/21)- Left eye swelling, decreased.

Client was observed for 15 min. after vaccination with no issues and left Clinic. Client returned to Clinic approx. 5 min. later. She complained of feeling her lips swollen and a little tingling. Client observed in Clinic. Benadryl 50 mg was given. Vitals remained stable. Client reported no tingling to lips and less swollen 1/2 hour after Benadryl. Client remained in Clinic for 1 hr. and 40 min. after Benadryl given as she was waiting for husband to pick her up. Upon leaving Clinic Client stated felt better, Lips feeling normal.

Chills, was very, very cold but had normal temperature, very thirsty, Headache, nausea, night sweats. Injection site soreness, more than my collogues. The lymph nodes in my injection site armpit and breast area were very, very swollen and painful, could not reach for or lift light objects without considerable pain for two days. Was able to reach and lift by third day and lay on my side again but still sore and swollen.

Facial paralysis on my right side, constant ringing in my ear, tongue is numb. Went to the ER and was told it was Bells Palsy

Triggered Asthma Attack at 12:30pm on 2/6/2021, Caused throat to become hoarse, raspy and sob. Extreme pain in left arm and swelling of arm and fingers. By 4:30pm on 2/6/2021 Hands Swollen, L Arm Extremely Swollen, Swelling of Lymph Nodes in Throat and L Armpit. Hands, Feet and Face Swollen. Extreme Fatigue and Body Aches, Extreme Headache, Fever 100-101 for 4 days, Vertigo, Dizzy Spells, Nausea, Joint Pain, Teeth Pain, Heart Rate and Blood Pressure Increased. Took albuterol nebs, antihistamine and napoxen, increased fluids, reported to director of pharmacy at work/vaccine site and was on bed rest for 4 days. Broke fever on 2/9/2021 in the evening, fatigue, joint pain, lupus symptoms, migraine, swelling in hands and vertigo/nausea still present as of 2/11/2021. Doctor Appt already scheduled with neurologist on 2/11/2021 at 11:30am, family physician notified but out of the office.

Painful pin feeling stabbing in the back of tongue, tongue swelled, tip of tongue went numb, lips went numb, pain in left part of chest, difficulty breathing, started to break out in hives, bloody nose. The medics did nothing for me as I am allergic to albuterol. After I felt like I could breathe properly, I went back to work and took some allergy medicine to help stop my reactions. It took four hours for the reactions to subside.

Moderna COVID-19 Vaccine, redness/itchiness/knot/heat from injection site. Feeling extremely tired, thirsty, body aches (head to toes), dizziness, headaches.

I received the second dose of the COVID vaccine on 2/8/21 around 11:30 am in my right deltoid. That same evening I had only pain at the injection site. When I woke up the following morning on 2/9/21, I had complete body fatigue, muscle and joint aches, and a migraine headache. The following morning, on 2/10/21, when I woke up at 5:00 am for work I had a sore throat. The sore throat rapidly progressed from mild to moderate pain. My sore throat persisted and worsening into the following day. On 2/11/21 my sore throat was still progressively getting worse so I had a co-worker (my charge nurse) inspect my mouth/throat. She told me it was swollen, red and spots on my throat/top of mouth. I left work and went to Urgent Care (on 2/11/21). They ordered a rapid beta strep test which came back negative. After evaluation, the doctor mentioned my throat being red, swollen and lymph nodes enlarged. He thought it was viral versus and an upper respiratory infection. I was not prescribed any medication when I was discharged. Over the next 2 days my sore throat worsened to the point of having severe pain, difficulties swallowing and talking, grossly enlarged lymph nodes, swollen and red tonsils, spots on the top of my mouth and throat, and pain in my ears, stiff neck, constant headache. I returned to Urgent Care on 2/14/21 at 9:00 am. The doctor ordered another rapid beta strep test which came back negative again. Upon inspection, the doctor quickly diagnosed me with peritonsillar abscesses (left greater than right). I was prescribed an antibiotic and a steroid pack. I have an appointment to follow up with an ENT (Ear, Nose and Throat) doctor in one week to ensure it is healing. Prior to this second vaccine dose, I was completely healthy. No illness. Not around anyone who was likely sick. I have never had an issue or illness related to my tonsils in my entire life. Since tonsils are a part of our body's immune system, I believe the vaccine triggered this adverse reaction (peritonsillar abscesses) I experienced.

FEB 15 I experienced headaches, light sensitivity, chills, temp of 96.6 DegF, vomiting, was unable to go to work.

At 7:15PM on Monday, 2/15/2021, I experienced blurred vision in the periphery of my right eye. At the same time, I felt some body tingling and mild numbness, most notably in my right fingertips. It lasted for approximately 3-5 minutes. After, the blurred vision and tingling dissipated, I had a mild headache across my forehead and eye socket area that felt like a pressure in the area. The mild headache continued when I woke up on Tuesday, 2/16/2021.

Extremely fatigue, nauseA, headace, right eye blood shot, right side jaw pain, swelling right side face , right side ear pqin

moderate-severe adrenergic response within 15 minutes after injection. Pallor, diaphoresis, nausea, dizzy, lightheaded, tachycardia, hypotension, weakness, numb toes, tingling in mouth. Given liquid diphenhydramine at site. Recovered.

SHE FELT DIZZY, HOT SWEATING DRY THROAT AFTER SHE TOOK THE VACCINE. ON SITE EMS RESPONDED. BP 135/88 TEMP 97.4 F. SHE WAS MONITORED FOR 20 ADDITIONAL MINUTES AND SHE WAS OKAY. SHE WAS RELEASED TO HOME

On Wednesday, Feb 17, I experienced an earache in my left ear and an eye twitch in the left eye, which continued to Thursday , Feb 18. On Feb 18, also experienced extreme fatigue and a jabbing, throbbing pain behind my left ear that came and went all day. I also noticed when I brushed my teeth that I had a hard time swishing water in my mouth, especially on the left side. On Friday morning, I woke up and noticed my left eyelid was drooping and my smile was lopsided. As I have a history of hemiplegic migraine, I assumed I was experiencing a migraine, although this was not the usual course of these migraines, and I had not had one of these types of migraines in many years. The left side of my head, behind my ear, and wrapping from my neck to my temple continued to hurt (but not as painful as a normal migraine). Thinking I was in a chronic migraine state, I took 40 mg of Prednisone, as I have done before to 'cut through' the migraine. When the facial weakness did not resolve by the next day, I suspected this was not migraine and instead suspected Bell's Palsy and consulted my physician. Looking back in time, I also realized that I had experienced some adverse tingling/taste sensations on part of my tongue as far back as February 8, that felt similar to burning your tongue from drinking too hot liquids that I realized later could have also been part of the Bell's Palsy.

5 am - sore arm - a little swollen. That evening of the second day at about 7 pm - I had body aches and a low grade fever. The third day, I felt back to normal and my arm was back to normal. The following week, the day after I tested positive for COVID, so that was January 7th. The arm was itchy and burny. It had a big rash on that area. (January 6 My upper back was hurting really bad and I had a fever. I wasn't feeling good at all. Had shortness of breath. So I went for a COVID test.) The rash lasted for about 48 hours and then it was gone. I didn't take anything for it. My other COVID symptoms lasted for about 6 days. I still didn't have taste though. I got that back on about day 10. I had the shortness of breath (feeling out of breath) which lasted a week and a half longer than when I felt better from the other COVID symptoms. I treated COVID symptoms with VIT C; Vit D3 and tylenol.

Felt hot and sweaty x 10 min. Felt like she needed to take her mask off. Denies SOB difficulty breathing or swelling of the tongue or throat 1445 BP was 133/89 P 76 R 16 O2 100% 1500 BP 116/81, P 73, R 16, 02 100%

Patient stayed for the 15 minute time period. Five minutes later her tongue became completely numb. She also stated that her friend described her as flushed. This occurred for almost one hour and then resolved on its own. This numb tongue sensation is not abnormal for this patient as it has occured when she eats seafood.

extreme dizziness ringing in ears vomiting elevated heart rate elevated blood pressure headache itching sensation under skin nystagmus transported by ambulance from home to the emergency room treated via IV, benadryl, meclizine, anti-nausea medication

A day or so after injection, severe fatigue, chills, feverish, amd slept almost all day and night. Fatigue, severe muscle aches, joint pain, headache, nausea, vomiting, upset stomach, chills to point shaking still come in waves. This is day 7 and I could barely put one foot in front other after work to get in bed but vomited first. Today, odd pressure in my face developed and headache came and went and again, the fatigue, muscle and joint pain are intense. I'm still working, but have had to take time off, go in late, etc. Brain fog is a thing. It feels like it did when I "didn't have COVID-19" before but had every symptoms and I was going to die, but in waves. I was dizzy, saw stars and black spots in my right eye today on and off and vision in my right eye honestly seems to have significantly decline. I'm really just concerned that it is day 7.

Dizziness; uncontrolled head shaking; low grade fever; burning eyes; pain in injection site; fatigue.

Patient had mild tingling and swollen lips after first dose. Took Benadryl at home. After second dose (aprox. 10 minutes after shot) patient again experienced tingling and swelling of lips. Patient offered PRN benadryl at site. Refused and said she would monitor at home after additional wait of 15 minutes. Waited 45 minutes total.

swelling under the armpit (left) swelling has under armpit has decreased no redness pain continues last night with right ear ache

Pt with multiple allergies and history of anaphylaxis/angioedema requiring intubation x5 per report. Received first dose of Moderna Vaccine and developed swelling of lips, hives, and acute shortness of breath. VS at 10:04: 116/93, HR 94, SpO2 on RA 83% exam w stridor, swollen mucous membranes, tongue and periorbital swelling. EMS Called, 0.3 mg of epinephrine x 2 (at 10:05 and 10:09) Administered with significant improvement in stridor, SOB, and improvement in lip/tongue swelling. Transported to ER for further care/evaluation.

dizziness, throat slightly closing, tongue swell, red face and neck, odd taste and drymouth, heart palpitations. This happened right when I left cvs after the 15 min, I should have went back inside. drove home and felt worried so stopped and grabbed bendaryl and spoke to a pharmacist at a Walgreens. Symptoms went away. Next day felt a little off. throat funny/tongue funny but not like the first day.

Within 10 minutes of the 1st Moderna vaccine dose, the patient developed chest pressure, a burning sensation over the anterior chest, a sensation of mild swelling of the mouth with a metallic taste. No rash, SOB, or n/v. The patient was transported to the ED for evaluation. On ED admission, the BP=151/107, HR=76, RR=20, SpO2=96%. All labs normal (CXR, EKG, CBC, troponin). The patient declined any medications for possible allergic reactions. The symptoms resolved quickly and the patient was discharged home. Three days later, the post-ED follow-up consult found the patient was experiencing cough and congestion. She was sent for a Covid test, which came back negative.

During observation period patient reported tingling feeling in lips which progressed to her tongue. She also was not sure if she had trouble breathing or if she was just feeling anxious. Gave her 50mg of oral Benadryl, administered an Epipen and called 911. Paramedics responded and took her to E.R. where she remained under observation for a few hours before being released with a prescription for Epipen. When paramedics evaluated her they said her condition appeared to be normal. Hospital instructed her to return if allergic symptoms returned.

Patient stated after she sat down she began to hear ringing in her ears and had tunnel vision; didn't remember after that; medic and this nurse ran to patient where she was laying face down. Patient began to come around and skin was pale and clammy to the touch. VS taken: HR: 82; BP: 140/70/ O2 Sat RA; 78%. Patient was speaking coherently after she woke up, was out for about 25 seconds. Patient stated she had a hx of fainting w/labs or shots. Placed cool, wet towels behind neck, forehead and lower back - patient stated it helped her feel better. VS retaken: BP: 134/66; HR: 77; O2 Sat RA: 98%. Patient sat up in a wheelchair and began to have color to face and feeling less clammy. EMT sat with patient until she was feeling better. Patient was joking and stated she felt embarrassed. Patient discharged to home. This nurse contacted her after clinic, she stated she was doing well and would be seeing us again for her 2nd Moderna dose. This nurse encouraged her to notify the next vaccinator of her hx of fainiting - She stated she would. Patient appreciative for call.

Flushing, lightheaded, sinus cleared 5 minutes after shot, extreme fatigue 2 hours after. Pain, harness, redness at injection site 6 hours after shot. Fatigue, sleepiness, floatiness , headache, palpitations, neck pain, right ear pain, 2 ulcers on left tonsil, sinus pressure lasted 3 days. Right lung/back pain upon exertion. Constipation 5 days without bm. Fatigue and palpitations linger.

Moderna COVID?19 Vaccine EUA 2/13/2021: chills, fever (101-102), body aches, headaches and slight nausea. Treated at home with tylenol. 2/14/2021: fatigue, slight dizziness. 2/15/2021: Asthma flare up, used rescue inhaler 2/17/2021: Eyelid swelling, itching, discharge. Went to Urgent Care and was diagnosed with an allergic reaction. Was given 60 mg of 60 mg prednisone, benedryl then took 20 mg of prednisone daily for 5 days. 3/2/2021: Eyelid swelling continue. Went to primary care doctor and was given erythromycin ophthalmic oinment usp .5% to use for 10 days .

Day of vaccine- has increased HR within 3 mins but resolved within an hour; severe headache, lip tingling, "loopy feeling" Day after vaccine: facial swelling, daily headache, fatigue 3/7: Itchy between her breasts and bilat arm, arm pit itching, lip burning, described "spiderweb like rash with visible capillaries"; throat itchy/swelling intermittently Taken benadryl without improvement H/O asthma, allergies:

Fever of 102. Body aches. Headache. Dizziness. Blurry vision. Confusion. Chills. Fatigue. Malaise. Extreme thirst. Sudden extremely painful sharp pains in ears, temple area, and left hip. These symptoms lasted 3 days. I still have the same sharp pains in my ears and temple area daily but not as frequently now.

Adverse Reaction: While at the vaccine clinic felt like eyes were puffy however they didn't appear puffy. About 4hrs after vaccination red hot raised rash appeared on the face by next morning the rash spread and was marbly on the back of arms. On the 10th bad migraine occurred had to take off the 11th. Severity flucuated to regular headache an back to a migraine level at worst scalp hurt to touch, pressure under scalp. Saw an allergist 2 days after symptoms started. Patient reports history of migraines, but never this intense, she got ear piercings in 2017 that relieved migraines.

I did not feel well almost right away, but decided to go home and rest. I been having severe headaches, achy arm for two days, body aches/joints aches for three days, sore throat, fatigue, achy skin, ears hurt/ached, warm temp (low grade 99.5ish, some chills, eyes were watery, became very sensitive to light - any exposure to sun/light brings on more of a headache or worsens headache, my eyes feel like they are "bugging out." The symptoms have been consistent across the last week. Early in the week I became restless at night/not sleeping well, ansty/racy, out of my skin, dizzy, and loopy feeling. Then sore throat increased Tuesday and it became uncomfortable to swallow. I could feel sensations down my throat, sternum and across my chest. I had an overall tightness with subtle itch. My tongue started to ache with a bad taste in mouth, burning mouth syndrome like, along with red dots all over my tongue and clustered more heavily on the front/sides. I also had other mouth sores come and go all week. My left ear had some ringing a handful of times and occasional hot ears the last couple days.

Dizzy spells that come and go, also feeling of ear ache and discomfort that happened within an hour of receiving the vaccine. They have not completely gone away since receiving the vaccine on 03-05-21.

Tingling/numbness in lips and nose, spread to hands and ams. Legs felt heavy. BP 155/87, pulse 96, 99% O2 sat.

Currently pregnant 12 weeks, date of delivery 23-Sep-2021. Shortly after injection, facial tingling and tongue numbness occurred and lasted about 10 minutes. It presented again the 2nd day with facial tingling and tongue numbness and lasted a few hours; also had a moment of hot flashes (which i dont have in general); face was flush. Tightness in neck muscles as well, but do have a previous herniated disk which seemed to be inflamed after injection. 3rd day numbness in roof of mouth behind front upper teeth and tingling in tongue lasted several hours.

Patient received the 2nd dose of the Moderna Covid 19 Vaccination on 3/09/21 in her left deltoid muscle. The patient reports that after her 1st dose of the vaccine she had some adverse reaction that included some facial swelling, that resolved with a single dose of Benadryl. She denied any other symptoms. Due to the patient report, she was monitored post receiving the 2nd dose of the same vaccine. Patient reported upper lip swelling at 10:30 am. Patient was given Benadryl 50 mg po at 10:37 am. Vitals remained stable and 02 was at 100%. Patient was released home following her observation.

1) After 3 days of Moderna Dose 1, on 1/23/21, I developed visual disturbances for about 15 minutes, where i have a constant bright round spot in my field of vision (LEFT eye only) that stays even after blinking. (Like the residual bright spot that stays after a camera flashlight flashes you). It eventually resolved without any treatment after approx 15 to 20 min. 2) Also with looking from my left eye, I also see some ripples on my top left corner of my visual field. (like water ripples), and that also lasted about 15 min. I have not encountered any eye issues of this nature before, and i had my last optometrist check in 9/2020 and all was normal. 3) Dizziness was experienced when moving and turning my head ONLY while lying in supine position after both doses. With 1st dose, dizziness lasted about 1 week while lying down, and with 2nd dose, dizziness was experienced for about 1 day only. No dizziness with standing and turning head. 4) Axillary lymph node on left arm (arm that shot was administered) was swollen after both doses that lasted for few days, then resolved. Swelling of lymph node was palpable, about the size of a pea.

After the 1st vaccine on 2/13/21 I developed a round red itchy ring around the injection site and some hives and itchiness on my face. I used cortisone and benadryl to help. My dermatologist advised me that I should still get the 2nd dose. On 3/13 I had my 2nd dose and on 3/15 I developed that round ring at the injection site again and a bad case of hives on my face and left hand. My eyelids were also very swollen. I then went to a facility in where they treated me for an allergic reaction with a dose of dexamethasone in the office and an RX for prednisone which I haven't started yet. This reaction came on much faster than the 1st dose and benadryl wouldn't help much this time.

During the 15 min. observation period post vaccination this individual reported tingling in the back of her tongue and feeling hot. Reported no difficulty swallowing, and no difficulty breathing. Observed for 30 minutes and released following report if decreased symptoms.

Medal taste in mouth within 10 minutes. Next day cold sore/fever blister in crease of lips left side. Day 3 cold sore/fever blister in crease of lips right side. 10 days later lips full of fever blisters. See by APN, prescribed VALACYCLOVIR HCL 1 GRAM TABLET, 2 tablets every 12 hours for 24 hours. Prescribed same medication again on 2/23, not staying gone. On 2/25 started ACYCLOVIR 400 MG TABLET 1 tablet bid.

Headache--24 hours in length Fatigue--48 hours in length Pressure in ears--8 hours in length Soreness at injection site--24 hours

PATIENT REPORTED DIZZINESS AND SEEING SPOTS SO PHARMACIST WAS CALLED TO HELP PATIENT. UPON ARRIVAL TO PATIENT, PHARMACIST ASKED PATIENT IF SHE KNOW WHERE SHE WAS AND PATIENT REPORTED A DIFFERENT LOCATION THAN FACILITY SHE WAS IN. AT THIS POINT, CALLED FOR MEDICAL PROVIDERS AND NURSES TO HELP ASSESS PATIENT. PATIENT'S VITALS WERE NORMAL, BUT THEN PATIENT STOPPED VERBALLY RESPONDING TO HEALTHCARE PROVIDERS FOR ABOUT 10-15 SECONDS. SHE THEN STARTED RESPONDING AND ACTING NORMAL. PATIENT WAS BROUGHT INTO EXAM ROOM WHERE PHYSICIAN PROCEEDED TO EVALUATE HER AND DO NEUROLOGICAL TESTS. SHE COULD NOT COMPLETE THE NEUROLOGICAL EXAM AND THEN BEGAN TO BE VERBALLY UNRESPONSIVE. SHE COULD ANSWER QUESTIONS BY BLINKING HER EYES, BUT COULDN'T MOVE OR TALK. EMS WAS CALLED AT THIS POINT. EMS TOOK PATIENT FROM CLINIC. PATIENT WAS CALLED A FEW DAYS LATER TO CHECK IN AND PATIENT REPORTED "Medical services released me to drive home since no other episodes occurred, only flu-like symptoms and I did not go to the ER."

I started out fine waited the 15 minutes and no change. But within 45 I started Itching everywhere, hurting, tongue felt weird, talking was difficult. I was very dizzy and as described by my co-workers I looked drunk and confused. I had a rash on my face that according to my co workers was like I scratched my face. I was very flush. Walking was very unbalanced. I took two Benadryl at work and my sister had to pick me up from work and take me home. Where I slept for quite some time. When I woke up I was not as confused but was still not all together. The next day I was just tired and sore.

Swelling of right arm around injection site at approximately 7:30pm 3/19/2021. Uncontrolled vomiting for 15 minutes began at 12:00am on 3/20/2021. Rigors, profuse sweating, two episodes of urinary incontinence during the vomiting. Soap like/chemical taste in mouth shortly prior to vomiting. Full body myalgias, lethargy, fatigue, and mild headache.

With both doses, eyes became swollen. Saw primary care provider and was prescribed eye drops and oral antibiotics which cleared the infection. PCP stated the "eye infection and stye" was caused by the vaccine.

3/24 headache about 2 hours after vaccine. 3/25 around 11:30am I started having numbness and tingling in my lower(bottom) lips. Throughout the morning and currently the sensations are going back and forth from numbness to tingling -- i also have a little swelling.

woke up on bathroom floor; lips tingling; soreness in the arm./painful; feel it (the arm) very heavy and hard to lift; had a tingling on arms; had numbness on arms; ears ringing; patient said it was in a lot of pain; broke in a lot of sweat; felt very weak; fell; over all fatigue; head was pounding; white blood cells were immature; A spontaneous report was received from an 40-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced woke up on bathroom floor, lips tingling, soreness in the arm/painful, feel it (the arm) very heavy and hard to lift, had a tingling on arms, had numbness on arms, ears ringing, patient said it was in a lot of pain, broke in a lot of sweat, felt very weak, white blood cells were immature, fell, over all fatigue and head was pounding. The patient's medical history was not provided. Concomitant medications included: vitamin d nos and iron On 04-MAR-2021, the patient received first of two planned doses of mRNA-1273 (lot/batch: 013A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient reported that when she got the vaccine felt the lips tingling but thought it was psychologic. She felt soreness in the arm, but the major symptoms started within 6 hours of being vaccinated. She started to feel it (the arm) was very heavy and hard to lift. It was very painful and sore. Because of the pain and how heavy it was. Then the patient said it had a tingling and numbness on arms and hands. The patient said that progressively got worst and worst and that 8 hours after receiving the vaccine had to go to the restroom, sat on the toilet and turned to grab toilet paper and when turned back saw that already had the toilet paper. The patient said that Feel, like losing consciousness already. The patient also said she went to wash her hands and that's the last that she had remembered. The patient reported that she fell and woke up on the bathroom floor, her head was pounding, ears ringing, the patient said she was in a lot of pain, broke in a lot of sweat. The patient said that though "what if I like die because of the head". The patient stated that around 12 hours after vaccination, she went to the urgent Care. On Urgent Care the caller said that they did an ECG, Blood, and urine test, and that the only thing they mentioned was that the white blood cells were immature. The patient said that when asked about it said that could be because has received the vaccine on the same morning. The patient said that she had a headache that lasted two days, 06-MAR-2021, the headache had gone away and came back in the afternoon, and on 07-MAR-2021 headache went away and returned at evening. The patient also said that felt very weak, and an overall fatigue after the first and second day. The patient has an appointment with the doctor 19-MAR-2021. The patient had not received any treatment and had taken Excedrin PM (Non steroid anti-inflammatory) just once before the vaccine. The adverse event of woke up on bathroom floor (loss of consciousness) was assessed as medically significant. Action taken with mRNA-1273 in response to the events was not reported. Outcome of the events of woke up on bathroom floor, lips tingling, soreness in the arm/painful, feel it (the arm) very heavy and hard to lift, had a tingling on arms, had numbness on arms, ears ringing, patient said it was in a lot of pain, broke in a lot of sweat, felt very weak, white blood cells were immature, fell, over all fatigue and head was pounding was unknown.; Reporter's Comments: This case concerns a 40 Y/O F with serious unexpected loss of consciousness and nonserious unexpected paresthesia oral, pain in extremity, limb discomfort, paresthesia, hypoesthesia, tinnitus, pain, hyperhidrosis, asthenia white blood cell disorder, fall and expected headache, fatigue. Event onset Day 1 of first dose of mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Modena COVID-19 Vaccine EUA My arm was sore from the moment the shot went in. The soreness continued getting worse. I awoke at 2am with fever and chills and body aches. I tossed and turned the remainder of the night. I got out of bed and couldn't walk, terrible lower back pain. "Bricks" in my neck - stiff. Severe headache. Eyes couldn't focus. These were all the symptoms I had when I had Covid in Sept. 2020. I kept up with fluids and Ibuprofen and rest for the day. Woke up today (3/26) feeling much better, though still a bit tired and 'weary'

Received vaccine in left shoulder at 9:30 AM Weds. By about 5:30 PM on Weds, I noticed that I felt tired and had muscle soreness in my left shoulder. By about 6:30, I felt feverish, chilled, and increasingly tired, noticed twinges of pain with movement of my right elbow. Felt increasingly achy in back, legs, hip joints and muscles, headache, and continued to feel fever/chills until about 11:30 PM Weds, when I took 2 ibuprofen and fell asleep. Woke at about 7:00 AM Thurs, still felt tired/fever/chills/body aches and soreness at injection site. Also noticed a strange sensation/hearing change. Not sure how to describe it, but sort of like I went up a mountain and my ears haven't popped yet, or my head is underwater or full of Jell-o. Lower pitched sounds seem especially distorted/loud/resonant, kind of uncomfortably so. It seems like it's taking me slightly longer to process what my husband is saying, maybe because it's sort of blurry sounding, or maybe because I'm just distracted by the vibration of it. My own voice makes my head feel like it's buzzing, if that makes any sense. I just read that Bell's palsy is a possible side effect of the Moderna vaccine; I don't have any facial paralysis or anything like that, but the Wikipedia article I was looking at mentioned "hyperacusis" and "dysacusis", which seem like what I'm experiencing. Maybe totally unrelated? (Also maybe totally unrelated: my father had a brief episode of Bell's palsy when he was 40. Treated with prednisone. Never recurred that I'm aware of.) The other symptoms (soreness at injection site, fever/chills, aches) all stopped by Thursday night, but the hearing weirdness (a clinical term) has persisted--this is Saturday night. Maybe it's a little better, or maybe I'm just getting used to it, but my head/ears are still not feeling normal.

post injection pt notied tingly tongue and felt her lips/mouth were swelling. she had an epipen in her purse that was administered and she felt better within 4-5 minutes

unconscious 3 times only for a second, kind of freak out, this is like immediately everything close and her vision turned black; like vision going blurring, blurred vision with spots, very vague even when lying down, had this 25-30 times and 5 time so far; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (unconscious 3 times only for a second, kind of freak out, this is like immediately everything close and her vision turned black) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history provided). On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (unconscious 3 times only for a second, kind of freak out, this is like immediately everything close and her vision turned black) (seriousness criterion medically significant) and VISION BLURRED (like vision going blurring, blurred vision with spots, very vague even when lying down, had this 25-30 times and 5 time so far). At the time of the report, LOSS OF CONSCIOUSNESS (unconscious 3 times only for a second, kind of freak out, this is like immediately everything close and her vision turned black) and VISION BLURRED (like vision going blurring, blurred vision with spots, very vague even when lying down, had this 25-30 times and 5 time so far) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. No treatment information was provided. Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.

Pt calls clinic on 4/16/21 about 8:30am to report adverse reaction to vaccine she received the previous day. Pt reports that while driving home after vaccination she suddenly felt difficulty breathing, dizzy, "like she was going to die". She drove herself to closest ED, and was treated for allergic reaction with epinephrine, pepcid and oral benedryl. She was released from ED later that same day. She reports having a "rough night", difficulty sleeping, felt like symptoms of lips tingling, throat tightening return when benedryl was wearing off. She has an epipen and her husband is home with her. She called her local PCP and has follow up appointment on 4/20/21. Pt calls in afternoon, around 3:00pm and reports no improvement and is taking benedryl more frequently, about every 2-3 hours. She is advised to return to local ED.

Feeling dizzy and bad; Thought her blood sugar was dropping; Lips started tingling; Started sweating; Felt weak; Felt pressure on chest; Muscles started twitching/legs started twitching; Had difficulty breathing; Anaphylaxis Shock; When the Benadryl wears off I start shaking; When the Benadryl wears off I have shallow breathing; When the Benadryl wears off throat starts tightening; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling dizzy and bad), BLOOD GLUCOSE DECREASED (Thought her blood sugar was dropping), PARAESTHESIA ORAL (Lips started tingling), HYPERHIDROSIS (Started sweating), ASTHENIA (Felt weak), CHEST DISCOMFORT (Felt pressure on chest), MUSCLE TWITCHING (Muscles started twitching/legs started twitching), DYSPNOEA (Had difficulty breathing) and ANAPHYLACTIC SHOCK (Anaphylaxis Shock) in a 40-year-old female patient who received mRNA-1273 (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Fruit allergy. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (Feeling dizzy and bad) (seriousness criteria hospitalization and life threatening), BLOOD GLUCOSE DECREASED (Thought her blood sugar was dropping) (seriousness criteria hospitalization and life threatening), PARAESTHESIA ORAL (Lips started tingling) (seriousness criteria hospitalization and life threatening), HYPERHIDROSIS (Started sweating) (seriousness criteria hospitalization and life threatening), ASTHENIA (Felt weak) (seriousness criteria hospitalization and life threatening), CHEST DISCOMFORT (Felt pressure on chest) (seriousness criteria hospitalization and life threatening), MUSCLE TWITCHING (Muscles started twitching/legs started twitching) (seriousness criteria hospitalization and life threatening), DYSPNOEA (Had difficulty breathing) (seriousness criteria hospitalization and life threatening), ANAPHYLACTIC SHOCK (Anaphylaxis Shock) (seriousness criteria hospitalization, medically significant and life threatening), TREMOR (When the Benadryl wears off I start shaking), HYPOPNOEA (When the Benadryl wears off I have shallow breathing) and THROAT TIGHTNESS (When the Benadryl wears off throat starts tightening). The patient was hospitalized from 15-Apr-2021 to 15-Apr-2021 due to ANAPHYLACTIC SHOCK, ASTHENIA, BLOOD GLUCOSE DECREASED, CHEST DISCOMFORT, DIZZINESS, DYSPNOEA, HYPERHIDROSIS, MUSCLE TWITCHING and PARAESTHESIA ORAL. On 15-Apr-2021, DIZZINESS (Feeling dizzy and bad), BLOOD GLUCOSE DECREASED (Thought her blood sugar was dropping), HYPERHIDROSIS (Started sweating), ASTHENIA (Felt weak), CHEST DISCOMFORT (Felt pressure on chest), DYSPNOEA (Had difficulty breathing) and ANAPHYLACTIC SHOCK (Anaphylaxis Shock) had resolved, MUSCLE TWITCHING (Muscles started twitching/legs started twitching) had not resolved. At the time of the report, PARAESTHESIA ORAL (Lips started tingling) had not resolved and TREMOR (When the Benadryl wears off I start shaking), HYPOPNOEA (When the Benadryl wears off I have shallow breathing) and THROAT TIGHTNESS (When the Benadryl wears off throat starts tightening) outcome was unknown. Not Provided The action taken with mRNA-1273 (Intramuscular) was unknown. The patient was treated at the closest hospital with epinephrine (epi pen), IV diphenhydramine, and IV Famotidine. The patient was having anaphylaxis shock (confirmed by Emergency Department). She stated epinephrine made her heart beat so fast that it was going to collapse. She was discharged 3 hours later from the hospital with epi pen (emergency use), diphenhydramine(as needed), Famotidine (as needed). Consumer stated that when the Benadryl weaned off she felt tingling of lips, starts shaking, muscles start twitching, throat tightening, and has shallow breathing. Company comment: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded. Anaphylaxis is consistent with the product known safety profile.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded. Anaphylaxis is consistent with the product known safety profile.

severe allergic reaction to the vaccine; became incoherent, could not function; I couldn't comprehend or process what my children were saying to me, I could see their lips; Vision blurry; dizziness increased; heart was racing; 154 heart rate; woke up with a "fever"; started throwing up; face started tingling; injection site swollen; injection site with burning sensation; Covid arm; injection site hot; injection site itchy; brain fog; became dizzy, the more I moved around, the worse it would get; It like an out of body experience; I was confused; woke up with severe neck pain; neck to collarbones were swollen; low grade fever, 101.9 degrees.; ymph node in both armpits and both breast were swollen and hurt to touch; chills; extreme fatigue, had no energy at all; headache; injection site was sore to the touch, it hurt bad, but looked fine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (severe allergic reaction to the vaccine), INCOHERENT (became incoherent, could not function), APHASIA (I couldn't comprehend or process what my children were saying to me, I could see their lips), VISION BLURRED (Vision blurry) and DIZZINESS (dizziness increased) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (Medical history not provided.). On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced NECK PAIN (woke up with severe neck pain), SWELLING (neck to collarbones were swollen), PYREXIA (low grade fever, 101.9 degrees.), LYMPHADENOPATHY (ymph node in both armpits and both breast were swollen and hurt to touch), CHILLS (chills), FATIGUE (extreme fatigue, had no energy at all), HEADACHE (headache) and VACCINATION SITE PAIN (injection site was sore to the touch, it hurt bad, but looked fine). On 05-Apr-2021, the patient experienced DIZZINESS (became dizzy, the more I moved around, the worse it would get), AUTOSCOPY (It like an out of body experience), CONFUSIONAL STATE (I was confused) and FEELING ABNORMAL (brain fog). On 06-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (severe allergic reaction to the vaccine) (seriousness criterion hospitalization), INCOHERENT (became incoherent, could not function) (seriousness criterion hospitalization), APHASIA (I couldn't comprehend or process what my children were saying to me, I could see their lips) (seriousness criteria hospitalization and disability), VISION BLURRED (Vision blurry) (seriousness criteria hospitalization and disability), DIZZINESS (dizziness increased) (seriousness criterion hospitalization), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE PAIN (injection site with burning sensation) and VACCINATION SITE SWELLING (injection site swollen). On 11-Apr-2021, the patient experienced PARAESTHESIA (face started tingling). On 11-Apr-2021 at 1:15 AM, the patient experienced TACHYCARDIA (heart was racing; 154 heart rate), PYREXIA (woke up with a "fever") and VOMITING (started throwing up). The patient was hospitalized from 06-Apr-2021 to 10-Apr-2021 due to ANAPHYLACTIC REACTION, APHASIA, DIZZINESS, INCOHERENT and VISION BLURRED. At the time of the report, ANAPHYLACTIC REACTION (severe allergic reaction to the vaccine), INCOHERENT (became incoherent, could not function), APHASIA (I couldn't comprehend or process what my children were saying to me, I could see their lips), DIZZINESS (dizziness increased), NECK PAIN (woke up with severe neck pain), SWELLING (neck to collarbones were swollen), DIZZINESS (became dizzy, the more I moved around, the worse it would get), AUTOSCOPY (It like an out of body experience), CONFUSIONAL STATE (I was confused), TACHYCARDIA (heart was racing; 154 heart rate), FEELING ABNORMAL (brain fog), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE PRURITUS (injection site itchy), LYMPHADENOPATHY (ymph node in both armpits and both breast were swollen and hurt to touch), CHILLS (chills), FATIGUE (extreme fatigue, had no energy at all), HEADACHE (headache), VACCINATION SITE PAIN (injection site with burning sensation), VACCINATION SITE PAIN (injection site was sore to the touch, it hurt bad, but looked fine), VACCINATION SITE SWELLING (injection site swollen), PYREXIA (woke up with a "fever") and VOMITING (started throwing up) outcome was unknown, VISION BLURRED (Vision blurry) and PYREXIA (low grade fever, 101.9 degrees.) had resolved and PARAESTHESIA (face started tingling) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: 101.9 (High) 101.9 degrees. On 11-Apr-2021, Heart rate: 154 (High) 154. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. The patient was taken to the emergency room on 06-Apr-2021 and was then hospitalized. Treatment details included hydroxyzine and IV (intravenous) steroids, and dexamethasone as well as IV fluids. The patient was advised by her HCP (health care provider) to not take the second dose of the vaccine due to having an allergic reaction. On 10-Apr-2021, the patient was released from the hospital but her injection site was sore, swollen and getting bigger. The patient reported additional side effects on 11-Apr-2021 that are ongoing. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Began sweating profusely within minutes over while body, hands ice cold but overall not feeling cold or hot, visibly shivering uncontrollably, throat discomfort - all resolved slowly over 4 hours following vaccination

Vaccine was given at 10:30 am on 12/29/20. The injection caused mild discomfort at the site (right deltoid) followed by swelling, redness, warmth, and soreness. The swelling, redness, warmth, and tenderness to touch worsened by 24 hours, peaked at 48 hours, and has since improved (but continued well over 120 hours post vaccination). Other than the arm discomfort, I felt well the rest of the first day however I woke at 1:30 am (15 hours post-vaccine) with severe muscle cramps in my lower legs and feet. I was freezing and had significant chills. PJs, a robe, and 3 blankets weren?t cutting it. I took Ibuprofen 600 mg and a robaxin 750 mg because the cramps were severe and unrelenting. Tmax was 100.5. Sleep was poor and intermittent. I got out of bed around 24 hours post vaccination and was extremely nauseous and weak. I took Zofran 4 mg and Tylenol 500mg and laid around the rest of the day. I forced some food down at hour 29 (had not eaten in 20-21 hours). My eyes and the injection site were itchy prompting me to take Benadryl 25 mg at hour 22. I got a second round of shaking chills, nausea, and worsened myalgias at hour 32. I also felt as though the injection site pain migrated towards my right axilla. Took a second dose of Ibuprofen 400 mg, Zofran 4 mg, and robaxin 750 mg and fell asleep by 7:30 pm (unheard of for me). When I woke to go to work at 6:30 am (44 hours post vaccine) I was still very achey and fatigued. My right axilla was very sore and tender to touch, moreso than the injection site. This same discomfort migrated to the right side of my neck and behind my right ear (which was worse by hour 55 and brought on a headache). Thank goodness it was a short shift due to the holiday! While caffeine and a third dose of ibuprofen and Zofran help me through the 6.5 hour shift I was still not myself. The fatigue and achiness did not let up until a little after 96 hours. I really didn?t feel like myself until day 5 (118 hours post vaccination) and the injection site and my right axilla are still sore and tender to touch. There is still redness and occasional itchiness at the injection site. I took my usual doses of Advair and Claritin despite the nausea all 5 days. I should also mention, that while on shift (hour 48-ish), I felt a very brief, unprovoked heaviness in my chest similar to the sensation I felt after I recovered from COVID in March. Sensation lasted seconds and came a few times throughout the day. No SOB, diaphoresis, or wheezing. That same discomfort started 2.5 weeks after I was diagnosis with COVID and about 5 days after feeling "fully recovered" from the fever, body ache, fatigue and nausea I had experienced with COVID. That chest sensation would come and go with decreased frequency over 6 weeks post COVID. I?ve had a total of 5 episodes of the chest heaviness but none today (day 5). I wonder if that?s what will happen with the vaccine. I also wonder if the side effects I?m feeling have anything to do with having had COVID 9 months ago. My husband and other ED colleagues who did not have COVID had no side effects with the first dose of the vaccine but the few colleagues that had COVID all had some degree of an adverse reaction to the vaccine. I never want to feel as bad as I did in March but I?m dreading my second dose of the vaccine. Is it recommended in my case? I should also mention, I had an adverse reaction to the pneumonia vaccine 1.5 years ago - arm blew up, no respiratory symptoms. Needed Benadryl and Prednisone. I?ve had a MMR booster and flu shot since with no adverse reaction. Not sure if it is relevant.

12/31/20 10:30a Vaccine given 10:48a Left the vaccine observation room 11:30a Started feeling warm like maybe my temp was increasing, face was red 12:00p had what felt like an adrenaline spike through my body became hot and jittery feeling. 12:30p The spikes started coming in waves, like a full body hot flash. Was very shaky and my tongue felt itchy and tight; not swollen just tight 12:40p made it home and took Benadryl 1:00p symptoms dissipated, ate a chicken salad sandwich thinking that would help with the jittery feeling. 1:25p The whole body flash came back and the tightness in the tongue increased. 1:27p Called employee health for information on this type of reaction. Wanted to call me an ambulance, I declined. After much discussion they suggested I come back to the vaccination observation room where they have epi, then decided it best that I go to Urgent Care. 1:40 on the way to town I told my husband to take me to the ED instead as my bottom lip felt swollen and tight, and my tongue felt thick like it was a bit swollen too. Was not short of breath, airway did not feel compromised, breathing normal, and heart rate normal. 3:01 Was given 40mg Methylpredinisone (solumedrol) & 20mg famotidine (Pepcid) given- immediate improvement in tongue thickness and swollen lips. 440p 50mg Diphenhydramine (Benadryl), 10mg loratadine (Claritin), & 40mg prednisone given prior to discharge 8:20p Top lip started to swell just before my next dose of Benadryl 8:30p Took next dose of Benadryl, once it kicked in had quick resolution of lip swelling 9:00p joint pain started setting in, was uncomfortable but not too painful 1/121 Joint pain is still present but not uncomfortable. Injection arm a little sore, no redness or swelling at site of injection. Swelling of mouth, face and tongue is persistent as it nears the 4-hour mark for 50mg of Benadryl. 1p ate a couple of bites of chicken fried steak, face is increasing in redness and swelling, and mild tongue swelling. At max dose of Benadryl per box states to only take 6 doses in a 24 hour period. 2p Mouth and face swelling not relieved with Benadryl 2:52p checked into ED for 2nd time. 4:08 Given 10mg dexamethasone (decadron), 20mg famotidine (Pepcid), 10mg montelukast (singular) Swelling improved. 5:54p Potassium low on lab work given 40 mEq of potassium chloride 6:00p discharge with scripts for famotidine, epi pen, montelukast 7:00p taken 25mg of Benadryl 8:20p lips feel mildly swollen again. 8:45p next dose of 25mg Benadryl. Did not have complete resolution of swelling but did improve. Mild hives, swelling of hands and feet. 1/2/21 All joint pain is gone, and injection site pain is only noticeable if someone bumps into my arm. 6a 25mg Benadryl & Pepcid 10a 25mg Benadryl 2p 25mg of Benadryl 3:30pm felt fine all day with only mild swelling and redness to hands, ate chicken nachos. Face became very hot (like my face was too close to the oven when I open it), redness from eyes down, lips swollen, mild itchiness too the tongue but nothing too concerning. 4p 25mg Benadryl I strongly believe the exacerbating factor is eating as all times the symptoms increased in intensity I had just eaten. After discussion with Dr. will be cutting out chicken (chicken was eaten before all 3 instances) and all other meats until complete resolution of symptoms and will avoid any inflammatory foods such as nuts, berries and shellfish. 7p 25mg Benadryl & Claritin taken 7:30p ate a banana, no reaction 8p Singular taken 9:30p put Vaseline on my lips, face & ears flamed hot and swelling and redness followed. 9:45p took 25mg Benadryl 10:25p tongue thick feeling 11p took 25mg Benadryl tongue still feels thick 1/3/21 Fevers 101.6 and chills started in the night Face and lips are permanently swollen and red despite all the meds I?m taking.Lymph nodes are all swollen. I?m too afraid to eat for fear of more swelling while my face is already so swollen.

Recipient reported symptoms of chest tightness, throat closing up, tachycardia and feeling flush approximately 2 minutes after the vaccine administration. She was taken to our outpatient clinic for continued observation. Vital signs: B/P 162/76, HR-124, O2- 100% she had relief of some symptoms but also reported right then left arm numbness and heaviness of the left eye. She was monitored for until approximately 3p. Last set of vital signs: B/P 10/72, HR- 81, O2- 100%.

Recipient reported chest tightness, throat closing up, tachycardia, feeling flush approximately 2 minutes after vaccine administration. B/P- 162/76, HR- 124, O2 sat. 100%. She was taken to our outpatient clinic for close monitoring. Some symptoms were resolving. She reported right and then left arm numbness with a heavy feeling in her left eye. She remained in the outpatient department for monitoring until approximately 3p last set of vital signs B/P- 109/72, HR- 16, O2 sat. 100%

1845 PATIENT REPORTS HEART PALPITATIONS, FLUSHED FACE, FEELING WARM, ICE PACK TO NECK, FEELING NAUSEATED. 1848 BP 161/114 HR 112. 1852 BP 148/91 HR 92 PATIENT RESTING. 1900-1910 PATIENT FEELS LIKE SHES "HAVING A DRY THROAT, "A LITTLE SHORT OF BREATH, AND TIGHT IN CHEST." BP 144/95 HR 84 SAO2 99%. ICE PACK TO NECK. PT OFFERED H20 AND JUICE. RELAXING WITH EYES CLOSED.1920-1928 BP156/97 100% PATIENT FEELING ANXIOUS. DEEP BREATHING. 1938-1949 PATIENT MOVED TO QUIET AREA UNDER OBSERVATION. BP 138/93 HR 81 SAO2 99%, FEELING BETTER, NO NAUSEA, SCRATCHY THROAT IMPROVING, DENIES SEVERE ANXIETY. 1959 PATIENT FEELING BETTER, NO RASH, THROAT TIGHTNESS OR ANXIETY, VSS, CHEST TIGHT BUT BETTER, PATIENT REPORTS SIMILIAR TO BASELINE. PATIENT STABLE WANTING TO GO HOME. AWARE OF NEEDING TO SEEK MEDICAL CARE THROUGH ER OR HER PROVIDER IF SYMPTOMS WORSEN.

Allergic reaction to COVID vaccination. Vaccine given at 10:00. Allergic reaction around 10:30. Same reaction as shellfish allergy: mucous in throat, tightening of throat muscles, loss of voice. Patient

EE starting with migraine about 5 minutes after receiving vaccine. That night had rash to trunk and back with the chills. Took benadryl that night. Next am, had swollen eyes and hands. Within 24 hours,those sx resolved- but then had 48 hours of sx similar to past covid infection.

Headache Per nursing: "took Moderna on last Thursday on January 31st,2020. C/o migraine headache on Friday morning. States had sore throat and sore tongue since before taking the vaccine but states feels like it's getting worse. Employee also c/o feels like her to Narrative:

12/29/2020-around 5:00 pm-sore throat and headache for couple of hours; minor blurry vision. Pain at injection site-hurt to raise arm to head 12/30/2020-little bit of nausea throughout day off and on-around 5:00 pm-fever (99.5), chills, headache, body aches, increased constant nausea. Moderate pain at injection site, redness 12/31/2020-fever (99.5-100.4), chills, nausea, headache, body aches until about 4:00 pm. Redness, swelling, moderate pain at injection site-(pain improved-able to move arm more than before), some minor itching off and on at injection site. 1/1/2021-Nausea, headache. Redness, swelling, pain at injection site-(Pain improved), injection site hard and hot to touch. Some minor itching off and on. Receive steroid shot from urgent care and took Benadryl 1/2/2021-Redness, swelling improved. Minor itching off and on. Took Benadryl. Had touch diarrhea. 1/3/2021-Swelling almost gone, redness almost gone. Minor itching off and on. Little nausea. Took Benadryl 1/4/2021-Swelling and redness gone. Minor itching once or twice-nausea briefly once. Took Benadryl 1/5/2021-Itching off and on-minor

Arm swelling and tenderness from wednesday until friday After, could feel hardness and it was itchy from saturday through thursday Still feels hard but no longer itchy Day after felt throat and ear pain but went away within a day.

Temperature at 6:00 am of 100.6 Temperature at 6:30 am of 100.7 Temperature at 8: 15 am 99.6 nausea for a brief period of time headache ongoing

Within minutes rapid onset feeling of facial and neck flushing + rapid heartbeat + increased resp rate + shaking. Lasted approx 2 minutes. Subsided then returned a few minutes later for approx. 20 to 30 seconds then subsided. Left facility with no treatment. Onset of swollen tongue evidenced by scalloping approx. 1.5 to 2 hours after.

Patient received the vaccine at 220pm via IM in her Left Deltoid. She stated that 10min later her top pallet in her mouth started to swell where she couldn't eat or drink anything. She stated it was tingly. She took 4 Pepcid and stated it felt better. on 1/8 at 1pm she reported a sore arm, cloudy vision, shakiness and a temp of 99.8. She reported to her PCP and her PCP stated not to get the 2nd COVID-19 injection.

Few minutes after injection - unusual taste in the mouth and sense of palpitation About 8 hours after - rash on the back of both hands, not itchy, lacy faint rash rapidly spreading limited to the hands, associated with tingling and paresthesia on both palms.

Approximately 11hours after receiving vaccine on 1/8/21, terrible chills and shaking began. The next morning 1/9/21 around 6am temperature rose to 100.4F. At 3pm on that same day, temperature went up to 102.6F. Took Tylenol 1000mg at that time. Continued to have terrible shaking and chills, also experienced a severe headache, eye pain, and body aches. Had diarrhea once on 1/9. Fever broke this am on 1/10/21, still feeling slightly fatigued with discomfort behind my eyes but improving from yesterday.

Feeling fine in morning. Had cup of tea, went for vaccine at 10AM. Did fine with injection, sat down for observation, 8-10 minutes later started feeling sweaty, then passed out. Woke up on the floor with nurses around me feeling tightness in chest, numbness in fingers, body shaking off and on, started to feel like tongue was swelling. Nurses gave IV fluids, oxygen and 2 Epi-Pens. Transported by ambulance to Buffalo General Hospital. Symptoms resolved not long after arrival at hospital. Remained in EMT bay hallway for observation., seen there by ER doctor. Another EGK done, additional half bag of IV fluids, released after 4 hours observation.

Warm sensation in chest 10 minutes after receiving vaccine, tight feeling in face 30 minutes after vaccine, tingling numbness in face 1 hour after vaccine, warm and tingly feeling down back between shoulder blades 1 hour 30 minutes after vaccine, ears felt warm and ringing 3 hours after vaccine, cool tingly feeling on entire back 8 hrs after vaccine.

I had my first COVID 19 Moderna vaccine Lot: 025J20-2A at hospital. Within about 60 seconds of receiving it, my heart started pounding hard and rapidly and I let a nurse know. She took my vitals and my heart rate was very high, as was my blood pressure. My O2 was fine. I had some tightness and heaviness I my chest. I felt flush in my cheeks, but did not have hives. The nurse said my color was very pale. I was warm, given an ice pack, and then a bit later cold. At one point they wanted me to go to the Emergency Department, which I refused (perhaps stupidly). I'm not sure I was thinking clearly. I was trying very hard to stay calm and relaxed. My blood pressure was very elevated for about an hour and a half. They finally let me go home when I was 140/95 (my usual is 110 over 70 ish). I had some tongue tingling at home, very briefly.

Patient given Moderna vaccine 1455. Patient reported feeling numb tongue, dizzy and nauseous. Patient took 25 mg diphenhydramine oral. Observed at vaccine clinic. began feeling more nausea. Tongue numbness not improving, took another 25 mg diphenhydramine. Patient sent to ED - taken by PALS/RN. Arrived in ED at 1600 complaining complaining of chest tightness with tingling in her throat. Out of concern that she may have progression to anaphylaxis so 0.3 mg of epinephrine was ordered intramuscularly. Patient also given 25 mg of Benadryl IV as well as Pepcid and Solu-Medrol. Patient was observed here in the emergency department for several hours. She did have some complain of some itchiness of her skin so additional 25 mg of Benadryl was given. She also was having some persistent chest tightness and appeared quite anxious and due to concern for anxiety is possibly a contributing factor, IV Valium was given for anxiolysis. On reevaluation, symptoms have improved significantly. She was counseled in regards to use of an EpiPen and a prescription was given for this. Prescription was also given per few days of prednisone and Pepcid. Provider recommended avoiding further covid19 vaccination.

Increased fatigue day or 2 following vaccine noted to have significant swelling of bilateral eyes. Fluid pockets present eye swelling first noted on 1/11.

My mouth became tingly approximately 15min after injection. My throat felt weird and mucus was forming in there. Had to clear it a lot . Felt itchy and flushed on my aroma and neck. Took two Benadryl but it didn?t really do much.

patient presented with left facial tingling, nausea and left jaw pain 6 days after receiving Moderna Vaccine, first dose. Exam negative for bacterial illness or extended weakness but CT ordered to RO cva. She did have bells palsy following childbirth(first child)

Tingling of tongue and lips approx. 30 mins after receiving the vaccine. Shortness of breath started 3-4 hours later. Did not see treatment until 1/12/21. Employee health nurse was made aware of side effect and lingering shortness of breath which persisted.

Vaccine on 1/12/2020. Pt reports minor dizziness after vaccine that subsided. No other associated anaphylactic type rx within 30-60 min after initial vaccine admin. Today 1/14/2021 woke up with right sided HA and now has swelling to her right upper lip. Took Xyzal and symptoms improved. There is no associated hives, rash, trouble breathing or swallowing.

Swollen Lip and left side of face Headache - left side is worse closer to face than head Taking Benedryl for swelling and ibuprofen so pain on left side head/face

2 minutes after receiving it I felt warmth sensation to deltoid followed by a weird taste in mouth and weird sensation in back of throat then hot flush sensation in upper abdomen slight but not really nauseated felt it it if I was going to faint but I didn?t then I felt numbness in upper left arm that progressed to left forearm and hand and some in left lower leg towards the anterior medial side I still feel it three hours after vaccine but much less

Injection given IM in patient's L deltoid. EUA distributed to patient per CDC regulations. Lot # 011J20A Manufactured by Moderna Patient filled out COVID 19 Immunization Screening and Consent Form. Pt presented to clinic 1/9/2021 for first dose of Moderna COVID-19 vaccine. 10-12 mins post vaccine pt began to feel warm/dizzy. Pt experienced a brief episode of syncope, shortly after pt regained consciousness , and then experienced 1 episode of emesis Pt was alert, reported hx of vasovagal type sx's, She was given juice, took Midodrine, and given IV Sodium Chloride 0.9% VSS Pt then reported feeling fast heart rate, EKG done w/ NSR Pt began to experience body tremors, HR 109, BP WNL EpiPen administered at 10:58 a.m. per provider's order Pt reports subjective tongue swelling , Second dose of Epi given 11:08a.m. Pt transported to Hospital via ambulance

none prior to getting COVID vaccine - was sick in March, 2020 unknow if COVID infection or not - with in 2 hours of getting COVID Moderna vaccine on01/07/2020 she started a sore throat and instant headache migraine type for 2 days continues with a mild throbbing headache at this time of 01/18/2021. also has light sensitivity, tried Toradol did not help headache, had COVID test and Strep Throat test, both were negative. unable to taste or smell all food taste bland. continues as of this writing.

Pt states her throat stated her throat felt like is was closing up. She had a burning sensation running down her throat. She began to lose her voice. I gave the patient 10m of Zyrtec liquid. After 30 minutes, she began to fell better. Pt had a hoarse voice.

One of the nurses noticed I was bright red, I got hives everywhere, the itching intensified, it was red and itching everywhere. My tongue was tingling and numb, they gave me something, I believe it was Benadryl, twice, 2 shots. I can't recall. I was like in shock, maybe after 4 hours later I started feeling a little better and returned to work. The next day my eyes and lips were swollen, a little bit puffy. I kept taking more Benadryl and I felt like I was hit by a semi truck for a week afterwards, it was awful. I was beyond exhausted. Mid week last week I finally started having my energy back.

Raised heart rate 168-203 bpm dizzy numbness lips tongue face flushed skin lasted approximately 45 minutes Severe headache for 48 hrs occasional lightheadedness is still present Monitored by nurse and dr on site for 2 hrs reclined on floor

Evening after receiving vaccine, felt "fuzzy, full feeling in tongue and throat". No breathing issue. Fever (101 degree) and rash (all over body, red, flat petechiae) developed 24 hours after vaccine with diaphoresis and general skin flushing, body aches and, severe local arm reaction. All symptoms resolved after 48 hrs.

I waited 15minutes at the facility and then began walking home. Approximately 30minutes after receiving the injection, my throat started swelling a bit and the back of my tongue seemed to swell, too. It was very hard to swallow. I removed my Covid mask and continued to breathe normally. Approximately 40 minutes after receiving the injection, I took 2 Benadryl tablets. The throat swelling eased but it was still much more difficult to swallow than usual. About 4 hours after my first dose of Benadryl, I took 1 more tablet of Benadryl. I fell asleep and woke up feeling completely normal with normal swallowing. Note: at no time did I have a rash, I did not wheeze, and my blood pressure and heart rate seemed normal. I have no history of allergic reactions beyond possibly reacting to penicillin when I was age 2.

About 10 minutes after the shot, my chest felt very hot and spread to both my left and right arm down to my elbows. Simultaneously, I experienced a weird taste in my mouth that was not metallic. My heart rate increased. I sought help immediately. My chest was a bit painful. That subsided a bit and then both arms felt tingly from my elbows to my wrists. That subsided and came back, milder each time. This lasted for about 50 minutes before I was allowed to leave and go home. I am typing this 7 hours later and my tongue feels a bit swollen (not unusual based on my food allergies and am not concerned to go to the hospital), and my chest still hurts a bit. I am wondering if it's anxiety at this point. My breathing and speaking have been totally fine. I got home with no trouble. I rested for several hours just to make sure I did not overexert myself.

swelling of the left arm, lymph nodes in arm and neck on the left side started within 60 mins. Woke up in the middle of the first night with extreme arthritis type pain in all of my upper joints. such as shoulders, elbows, wrists, neck, back and hips. The arthritis like pain continued in all of my upper joints in different locations for the next 6 days. On Monday Jan 4th when I woke up I had extreme vision issues in my right eye for about 6 hours.

On the afternoon of 01/19/2021 this patient called Health Department to report that she started experiencing "drawing and tightening of the lips" about 9:30pm on 01/18/2021. Pt stated fear of having a stroke and presented to Emergency Department soon after. Patient stated was informed by the ED physician that patient possibly had Bell's Palsy related to the COVID-19 vaccine received (01/13/2021). Pt described that symptoms had "mostly" resolved by time she left the ED after midnight and that was completely resolved when awakened from normal sleep at 7:00am today. This RN obtained patient's visit note from the 01/18/2021 event. Summary as follows: Pt presented to Emergency Department with complaint of perioral paresthesia and earlier in the evening that sides of mouth "drew up." Pt feared stroke and presented to ED. Mild paresthesia persisted. Neurological exam was negative. No unilateral deficits. Speech intact. NIH Stroke scale was 0. MD's note states patient was advised that the symptoms could be associated with hyperventilation syndrome or could be early manifestation of Bell's palsy with the recent vaccine administration (five days earlier). Pt was discharged from the ED without finding anything to indicate need for further work up or admission or the presence of an unstable medical condition. Pt was reminded to take BP med as prescribed due to patient stating had not yet taken evening med dose.

tingling tongue immediately after but checked by medics and nothing serious. told to take an antihistamine. later that eve itchy eves and the next day a bad mood and my tongue peeled a little, briefly. all pretty mild though.

Monitored patient for 15 minutes without reaction. She left the clinic and on her drive home started having numbness in lips and face,only L side, noticed small lump in L side of throat. On arrival at Seminole ED she received a "steroid injection" and was instructed by medical professional to take a oral Benadryl once she was home. She was alone and driving herself. No other treatment or extended observations necessary.

On 1/8/21 I had pain in my left ear and a feeling of fluid like an earache, also had a pressure type headache behind my eyes and felt fatigued. I stayed home from work and reported it and was told I could return to work on 1/11 (my next scheduled day) by workplace health. I felt fatigue and eye pressure headaches on and off since. I also felt like I was having vision changes. On 1/14/21 I noticed a small, raised, red area at the injection site. Over the weekend it continued to spread over my arm. It is warm and very mild tenderness to palpation but does not itch. I am also feeling tight muscle pain in my left shoulder and left side of my neck.

Patient?s lips and eyes swelled.She reported tingly lips, felt shaky. EMT took BP was136/74. She was observed by MD over one hour. She was assessed as no longer having swelling and reported feeling better. She planned to go home and take benedryl.

Severe headache, nausea and cold sensation occurred within a few hours of receiving the vaccine. Arm discomfort and fatigue quickly followed. Low grade fever noted approximately 8 hours post vaccine. I took acetaminophen. Headache, fatigue, and fever/chills resolved within about 48 hours. Nausea and arm discomfort persisted for about 5 days. After approximately 48 hours, I noted vision changes, blurry up-close vision. This change might have occurred sooner, but it was not until this time that I felt well enough to really read. The change in vision led me to seek further evaluation in the emergency room on 1/16/2021.

Within first 15 min my throat started to feel like it was closing up. My tongue also felt like it going towards the back of my throat and I was dizzy/lightheaded. It lasted. About 5/7 min. It felt like was easing up so the school nurse told me wait an additional 15 min to be sure I was ok. She also took my blood pressure and said was normal. Dr. a pharmacist brought me orange juice a d said maybe was just low blood sugar. I said it felt similar to when my epidural during last delivery was up too high and my throat closed up and I couldn?t breathe. About ten min later it began again. I tried to get up and walk around some and I felt a little better at first but then started to get significantly worse. I felt like I was struggling to breathe and tongue was swollen feeling and stuck to back of mouth as if it was paralyzed. I say back down and my blood pressure was high (just told bottom number was 106). I was moved to another room to lie down and pharmacist mentioned using epi pen or benedryl shot. I had to sit up and almost passed out. I was having difficulty breathing. Not because of my lungs but my throat and tongue seemed frozen. He decided to give me a 25 mg Benadryl shot but had me drink it. It had a horrible bitter taste and made my throat and tongue numb. At this point it was about 12:30. My administrator called a coworker to drive me home. I decided to leave about 29 min after I had the benedryl. I could still feel that my throat was somewhat tight but it had improved enough that I didn?t think I was in danger of not being to breathe again. I went home (15 min drive) and by then my throat felt a lot tighter. I took 25 mg more of benedryl and it felt better. About four hours later it became tight again and I took 50 mg of benedryl. Through out all this I had severe pain at site of injection in my left arm, dizziness, nausea, and headache.

After receiving my first dose of the moderna vaccine I felt my heart begin to flutter for several minutes. I lost feeling on the left side of my face and my tongue became numb. The symptoms remained for well over five hours until I took two Benadryl. Then the symptoms subsided. I have had a terrible reaction to the drug Compazine in the past which resulted in loss of motor control in my face. While I never lost control of my motor functioning after receiving the vaccine, the loss of feeling in my face was similar to my past reaction to Compazine.

Blurry Vision - started around a week after vaccine - I have not been to eye doctor but vision has changed

Moderna COVID-19 Vaccine EUA An all over headache started around 8 pm on 1/19/2021, then every single joint in my body started to hurt and ache, low grade fever of 100 degrees, fatigue, and ear ache in the left ear and continued until 1/21/2021. Headache and fatigue is on going today 1/22/2021.

Had jaw pain and swelling beginning 1/17/21, went to PCP 1/18/21 and she noted bulging ear drum but no real redness and said it could be an ear infection. (Did not have ear pain). Prescribed cefdinir and hydrocodone. Pain and swelling to the jaw worsened and then on 1/21/21 had spread to the neck and chin. PCP suggested I report to the ER where he did a CT scan and lab work. Lab work was wnl scan showed swelling to the lymph nodes. Diagnosed with lymphadenitis. Given a single does of steroids and told to continue the antibiotics to test any infection I might have.

Mouth tingling and burning, throat feels a little swollen, mouth tastes like metal, itchy hands and head, loss of clear verbal articulation

Moderna COVID-19 Vaccine Facial numbness around cheek area and tingling in lips and tongue within 15 mins of receiving injection.

vaccine site soreness very thirsty chills body aches diarrhea fever 101.4 acid burning feeling in stomach

After 5 minutes I felt warm come over my body, tingling especially in my hands , I just did not feel right , my body felt weak almost like I may faint. My head was very woozy and I was not able to stand up. I could barely keep my eyes open and I wasn?t sure if I should go to the hospital.

Endorsing nausea, shortness of breath, throat swelling, tingling in tongue. EMS called and IM epinephrine 0.3 mg given. Follow IM epinephrine she reported improvement in mouth/tongue tingling, worsening nausea and shortness of breath. She was transferred to the ED for worsening/persistent symptoms. In the ED she was observed 2.5 hours, given Decadron, H1 and H2 antihistamine and IV fluids and discharged home.

1/21/21: Immediate swelling at injection site, hot to touch and arm soreness 1/22/21: I woke up at 7:30am with a sore throat and right ear pain. This is typical for me when I am starting to fight something off. I was managing okay until around 1pm when I started to low grade fever at 99.8. By around 4pm, my body was really starting to ache and I was getting chills. After the training, I took some Thera Flu, but I couldn?t really move from the couch to the bed because my body was so sore. My fever fluctuated between high 99?s to low 100?s. I felt like I got hit by a truck. I managed to fall asleep around 8:00pm and was able to sleep until 1:00am. I took more Thera Flu, water, and was able to fall back to sleep at 3:00ish am. 1/23/21: I woke again at 11:00am and my aching was still there but not nearly as bad as the previous day but now I felt heavy congestion in my head and chest. I also had sneezing, and a stuffy then runny nose off and on throughout the day. I was also very, very tired and had no energy to do anything but lay there. Today is when the diarrhea started 1/24/21: Body aches at this point are still tolerable but I?m sore. My arm injection site is bruising and starting to itch and still slightly warm to the touch. I have sneezing, a dry cough, and an off and on runny nose and diarrhea 1/25/21: Body aches are mild today, dry cough is here, post nasal drip mucus I am assuming as well. All I want to do is sleep. I?m so tired. No diarrhea today so far but I haven?t had anything to eat yet.

After 15 min I walked to my car. In car felt NUMB LIPS, FAST HEARTRATE, over the next 3 hours I felt EXTREME DIZZINESS, LIGHTHEADED , CONFUSION, THROAT SWELLING, NAUSEA, FOGGINESS, FLUSHED, WEAKNESS and TIRED. I felt like I might die, yet I couldnt do anything to get help because I was out of it. At the first signs I sent my Doctor a message that said "Got my shot today. Have extreme dizxziness., fast heart rae,, num blips, fogginess. Lump in throat . Is this normal feel hotl? They sent me back a phone number for covid. I called the number and asked for help, they told me the symptoms of the covid shot, not the reaction. They did not offer help.

Taste of vaccine after 10 minutes immediately following increased heart rate. Alerted staff and was taken to room for observation, BP check. BP 200/ 100 and heart rate increased (baseline BP 130/85). Throat felt numb and scratchy. Given diphenhydramine and BP checked after 15 minutes with noted decline. After 45 minutes was released. Ongoing symptoms of throat discomfort and periodic heart palpitations over next 4 days. Self- treated with propranolol used for anxiety and diphenhydramine. Reported effects to neurologist after day 4. Fully recovered after day 7 post-vaccination.

Initial reaction: within minutes of vaccine lightheaded, slowed reaction time, hypertension (178/95), dizziness, stayed in clinic x1 hour until symptoms improved. water/OJ. Fatigue began that afternoon. Took 400mg ibuprofen before bed. At 3am the next morning, severe chills, fever, severe muscle and joint aches, vomit x1, Continued ibuprofen 400mg q6h until vomiting, then could not medicate. Symptoms continued, including fever 100.5-101.5, and lightheadness with ringing in the ears and black tunnel vision when standing throughout the day. Dizziness resolved that evening but chills and cold sweat, joint pain continued. Some diarrhea day 3. Today, continued sensation of mental fogginess and fatigue.

The patient woke up Saturday (1/23/21) with a sore arm and also woke up a little late (for her) with a headache. The patient also felt like she wanted to throw up. The patient went to the bathroom, then started seeing light spots. Shortly after the patient went to the floor. Her husband said that she had a seizure. Said she went stiff, arms were pinned down, eyes open and fixed for 20-30 seconds. and then went limp and sweaty. When she came to, she was nauseated and weak. She took Zofran and slept most of the day. She woke up Sunday and felt fine.

Swelling of face and eye area began on 1/15/21 until 1/20/21 Itchy bumps on face,neck,shoulder, waist, arms, hands and legs began on 1/13. It started on face and began to spread. Itchiness still persists.

Patient received first dose of Moderna COVID-19 vaccine today at approximately 07:35 hours. Approximately 5-8 minutes after receiving vaccine patient experienced dizziness, head "fullness", headache Left>Right, tingling and numbness of the lips and diaphoresis. Patient verbalizes a history of Anaphylactic reaction to Aspirin as a child. Patient does have anxiety and took anti-anxiety medication this morning. ERT was called at approximately 07:49 time. Disposition: Emergency response team arrived and assumed care of patient. Patient WAS transported to emergency department via wheelchair for further evaluation at 07:59. In ED patient received diphenhydramine 50mg po. Was monitored and discharged.

Within less than 10 minutes of receiving the vaccine I began to feel a tingling sensation inside my mouth. That moved to my lips within the following 10 minutes and my pulse increased. I received benadryl at the triage area of the vaccination clinic and monitored. My BP was unusually high (140/90). In the days that followed, the injection side was swollen and raised, the muscle around it knotted, and incredibly painful. I had some slight symptoms such as headache and nausea. Those all subsided by Friday, 1/22/2021. One week later (today, 1/26/2021) the injection sight is suddenly reinflammed; the knot has returned and is larger than before, the skin is raised and red and hot to the touch, and it is extremely itchy. I was advised at the vaccination clinic that I would be able to receive the second dose, but that I should take benadryl prior to receiving it. Now I'm wondering if I should receive it at all. Why should it be reinflammed, a week later?

5 minutes after my body begin to feel warm and I begin to get light headed and my upper brow began to swell. I was laid down and my BP and BS wd elevated so I was take to the ED where I was given benedryl, pepcid and tylenol . I was released with a Epi pen and while at home my tongue starting feeling a little furry and swole a little but I continued to take benedryl for that but I had a bad headache that lingered for the next 2 weeks after wards

patient hand numbness and tingling to hands and feet, complaints of feeling warmth throughout entire body, felt weak an faint. Heart racing and just did not feel right. was observed for 1-1/12 hours. Upon driving home and getting home, throat felt a bit full, had chills, was shaking, felt feverish. Less than 24 hours later was very achy, flu like, and arm felt dead.

within minutes of receiving dose of vaccine complaints of numbness, tingling, not feeling right. within 4 hours feeling feverish with shakes and chills. throat fullness at one point. less than 24 hours body aches, dead arm feeling,

Almost 12 hours after receiving vaccine I had numbness and tingling on inside of mouth/cheek on the right side, numbness of right side of face, swollen right eye and slight dropping of right bottom lip

Shortness of breath, swollen tongue, smooth spots on tongue. These symptoms lasted 24 hours. 7 days after vaccination I had a 5" rash at injection site.

ON DAY OF VACCINATION, NO SYSTEMIC SIDE EFFECTS NOTED. aPPROXIMATELY 3-4 HOURS POST VACCINATION I DID EXPERIENCE A ORAL DISPLEASENT TASTE OF METAL OR COPPER FOR ABOUT AN HOUR. THE FOLLOWING SATURDAY JANUARY 23, 2021, I BEGAN FEELING THE SENSATION OF NEED TO ITCH THE ARM OF INNOCULATION. THROUGHOUT THE DAY I EXPERIENCED THE SENSATION 3-4 TIMES. LATER THAT EVENING WHEN I DID ASSESSS THE FULL AREA, THERE WAS A LARGE AREA OF LOCALIZED ALLERGIC (WELT) REACTION WHICH WAS ACUTE. THE AREA MEASURED 6X3 AND HAD A RAISED, BORDERED EFFEACT THAT WAS WARM TO THE TOUCH AND RED WITHIN THE AREA, WITH A HARD PALPABLE SPOT WHERE THE INNOCULATION OCCURED 1 WEEK PRIOR. THIS EVENT WAS NOVEL TO THE DATE OF 1/23/2021. ASSESSMENT DESCRIPTION WOULD APPEAR TO RESEMBLE CELLULITIS, THE AREA HAD IMPROVED OVER THE COURSE OF 2 DAYS BUT THERE TO DATE IS STILL A SENSATION TO ITCH, AND A CRUSTED SCAB AT THE SITE OF INJECTION. i AM CONCERNED AS TO WETHER OR NOT i SHOULD RECEIVE MY 2ND DOSE. i ALSO AM PERSONALLY A VACCINATOR AS WELL AS LOGISTICIAN AT THIS POD FOR THE HEALTH DEPARTMENT I AM A LICENSED RN.

Within 5 minutes of COVID - 19 Vaccination employee reports her tongue felt numb. 45 minutes later in her office her tongue began to swell. Took 800mg Ibuprofen, 25mg Benadryl. By 5pm symptoms appeared resolved. Saturday developed 3 - 4 sores on her mouth/ gums with pain 3 out of 10. No meds taken. Edema resolved. Sores remain in her mouth as of 1/15/2021.

Approximately 60 hours after I woke up with my tongue swollen. I felt faint and could not concentrate well. I took 2 Benadryl and my EpiPen. I used Benadryl for the next 72 hours. Today is 8 days since the injection and the injection site is becoming warm to the touch, hard and itchy.

Started within 2 hours of vaccination. Chills, fever, dizziness, nausea, widespread itching,/rash, swollen arm, joint pain, abdominal pain, diarrhea, tingling in arms and legs, tongue.

Swelling of eyelids, burning, hives on eyes face arms and legs. Fatigue joint aches. Started the morning after. My eyes lids are still swollen and burning but body hives have subsided. Fatigue and joint pain continue

11:17 am: tingling in tongue; denied assistance 11:29 am: complained of sore itchy throat, worsening tingling of the tongue; patient denied epi pen, accepted Benadryl VS WNL through out observation. She continued to report improvement of symptoms throughout observation period, 12:01pm. Patient declined any further treatment and went home where her husband was. She did agree to call 911 or be driven to the ED with any worsening of symptoms. 4:00pm Doctor was made aware of event with patient permission as requested by HD Medical Director. 4:15pm RN, made phone contact with patient and she stated that all symptoms have resolved.

Chills approx 36 hrs Headache (light sensitive, sound sensitive) >48° muscle & joint achiness - 48° skin sensitivity - 24° dizziness - 12°

Neck and jaw stiffness/pain started 45 mins after injection. Then Whole body aches. Started taking ibuprofen and Benadryl. Next several days had joint pain in bilateral shoulders,elbows,wrist and hips. This lasted 4 days. Legs ache mostly calves. One week later developed rash on left side of arm and chest. It has been 4 weeks now and still having ashiness in legs mostly calves. I feel that all my lymph nodes in my body are swollen. I was perfectly fine before covid vaccination. I Had none of these symptoms before getting vaccinated.

On 1/30/2021, I developed a mild headache followed by an acute change in my vision. I went to the emergency room 24 hours later after the symptoms had not resolved and was found to have a left superior quadrantanopia and a 2.3cm x 1.9cm hemorrhage in my right occipital lobe. I was admitted to hopsital and discharged today 2/3/2021. My headache has resolved but I continue to have a visual field deficit. I had been scheduled to receive the second dose of Moderna on 2/1/2021 but was unable to receive it due to my hospitalization.

pt stated she experienced dizziness, heart racing, numbing and tingling of the tongue and arms. Pt BP and Pulse were measured, and showed elevated. We tried to get her breath and stay calm. Paramedics was called to assist. Vitals improved after paramedics arrived

Within 5-10 minutes of the shot I started to get a metallic taste in my mouth. Then my legs started to feel heavy and numb, then my face felt numb and then my arms. I could barely pick something up and I could not stand. Then my jaw started to shake and so did my legs. I went to the ER and they said I was having a shock/panic attack response to the vaccine. On Monday 1/25 I woke up in extreme stomach pain and went back to the ER and they said I needed to have my appendix out. I went to a hospital where they tried to just give me antibiotics, but still had to have my appendix out on Wednesday 1/27.

Headaches, migraine, tiredness, feverish (chills, aches, hot skin), nauseous, food tastes odd, general feeling of unwell, anxiety, uptick in CRPS symptoms, clogged ears on day 12. Still have all symptoms on day 13. Prescribed prednisone 20 mg, two pills a day for four days and one pill a day for four days

Patient received Moderna vaccine lot 042L20A at 1623 on 01/25/21. Later that evening she felt off- partly because the air was off in the ER and she took her pulse ox and HR and HR was 97 o2 was 91 reports no rash at that time. Came home and took a cool shower and 25 mg of benadryl. Morning of 1/26 she noticed a fine rash on her left lower neck and upper chest. She had Dr. look at it when she got to ER to work- they thought it looked like heat rash (air was still out). Her skin felt uncomfortable and rash worsened to where a co-worker noticed. The NP checked her and it had spread to her abdomen and back - not legs. It felt like fire and was painful, but did not itch.

The patient received dose 1 of the COVID Moderna vaccine at around 7:00 AM on 2/8/21 at her place of work The patient came back to the vaccine area around 10:00 AM saying she was experiencing shortness of breath, jaw pain, tingling in her left arm, and chest tightness. Her blood pressure was 188/120 mmHg at 10:05 AM with a heart rate of 105 bpm. The patient said she had had a heart attack a year prior. We called 911 at around 10:12 AM. EMS arrived and took a manual blood pressure of 178/118 mmHg, and took the patient to the hospital shortly after.

Patient vaccinated at 2:37pm. At 2:46pm, patient reported throat tightness, tongue tingling, and extremities tingling. Administered liquid Benadryl 25mg at 2:46pm. Continued to observe patient for 30 minutes. Vital signs remained WNL throughout observation period. Patient reported overall improvement 15 minutes after Benadryl administered. Symptoms diminished by end of observation period.

Severe left ear pain and fullness with associated right side complete facial paralysis. I was diagnosed with Bell's Palsy 1/9/20, 5 days after getting my first moderna vaccine.

Starting 1/27/21 ringing in left ear noted. 1/28/21 headache and left ear pain begins. 1/29/21 Started on Cefdinir for Left otitis Media. Ear pain continued and began to worsen over a week with headache pain in left temple and all the way down through neck. Pain was throbbing and Ibuprofen/Tylenol had to be taken around the clock. On 2/6/21 began Prednisone pack for possible nerve pain. Pain has eased over the past 5 days. Continues now left ear and left neck, however very mild.

About 25 minutes after receiving vaccine, Patient complained of weird feeling and tightness in her jaw and throat. Upon trying to drink water, she started to feel sick and dry heaved (never vomited) then she said she had problems trying to swallow. She did not report trouble breathing. I called 911, they had me ask her a series of questions. As soon as she said her throat was bothering her again, I administered the EpiPen at 12:10. We also called her emergency contact person.

Fatigue 9pm Chills 10pm Headache, dry mouth, body aches 1am woke me from sleep Headache, nausea, fever, sweating, body aches, tingling 8am Slept 30 hours and then felt better just very mild fever and left sided neck pain

Within 20 minutes of receiving vaccine patient reported dizziness, lip tingling, metallic taste in mouth, swelling to eyes, and difficulty swallowing. Patient was assessed by provider at 1500. She received oxygen 2 L via nasal cannula, Epinephrine 0.3 mg IM, followed by diphenhydramine 25 mg IM for allergic reaction. EMS was called and patient transported to Hospital Emergency room at 1530

Day 1, I was fine. The next day, I felt like I had a fever but it wasn't showing per thermometer. I had shooting pain anywhere I scratched too hard. Two days later I still had nerve pain. Nine days after vaccine, I noticed the flat patch on my arm at vaccine site. Really wasn't itchy. Friday, the flat patch was elevated and swelling. Upper lip was itchy and my face was asymmetrical. I am allergic to most tree nuts, but not all. I can usually eat pecans and I did have one. The patch grew from Thursday, and the largest it got was 5 3/4 inches. I never got a fever during all of this. I took Pepcid along with ibuprofen for treatment.

COVID vaccine lot 025L20A Patient reported to the nurse at her second COVID vaccine shot that her right eye became red and irritated 4 days after her first COVID vaccine. Patient reports that she called her ophthalmologist who agreed it was an allergic reaction to the vaccine.

Tingling lips and nausea after receiving COVID19 vaccine. Took PO Benadryl 25MG and also 50Mg IM Benadryl with relief of symptoms.

approximately 15 minutes after receiving the covid vaccine pt c/o lightheadedness, itchy throat, which progressed to numb lower lip and then numb upper lip extending to lower nose

Patient received first dose of Moderna COVID19 vaccine on 29Jan21. She states the day following her vaccination she had approximately a sand dollar size area of erythema, induration, and warm located on her left arm. Pt denies any numbness, tingling, pain or swelling down her arm. The swelling remained localized. Denied any bruising at the site. Patient states upon awakening on 03Feb21 she felt the left lower lip was tingling/numb and slightly swollen. Over the next hour noticed that the numbness/tingling then started moving over to the right lip. Pt took benadryl and symptoms subsided. Pt states she has equal movement of both sides of her mouth, denies any drooping. Able to eat and drink without dribbling. On 09Feb21 patient went to UCC again due to chin swelling. She was diagnosed with topical bacterial infection and prescribed antibiotic ointment. Denies any lymph node swelling. She no longer had erythema or pain at the vaccination injection site. As of 17Feb21 all symptoms have resolved.

My arm started hurting again on Saturday/Sunday. It was also getting a bit itchy and I noticed red dots around it. On Monday my arm was hurting and warm to the touch. It was also a bit swollen and itchy. It?s now Wednesday and my arm has a red circle and super itchy.

As soon as I received the vaccine it felt like I drank a hot alcoholic shot, my throat was thickening and hard to swallow, tingling and numbness on my face I felt hot inside and cold shivering, I was a little out of it, very tired nauseus and I had a really hard time swallowing saliva, 30 mins later I had no feeling in my face, my lips felt huge like I had just had novacaine, my eye felt like it was drooping, I went to employee health I was given Benadryl and I took it for two days and one day I did not take the Benadryl and my face started drooping all over again so I took Benadryl and it went back to normal. I was advised not to get the second vaccine. I fully recovered.

Received the vaccine Friday around 11:40 am. Arm was sore and had joint/body aches that evening. Saturday 2/20, 24 hours after getting the vaccine my tongue started to swell up/ was splotchy/ had bumps allong the side and my throat was scratchy. My breathing/asthma was also triggered and I increased use of my albuterol. I took benadryl with minimum results, but symptoms did not get severe enough to go to the ER. The next day, Sunday 2/21 my tongue was still swollen and my jaw/ face were also sore and had inflammation. This was in addition to the sore arm/joints.

Individual complained of feeling a little tingling in her throat and on her tongue. The assigned PA directed that staff member would need 2- 50 mg Benadryl capsules PO. Yes- we did have an epi pen next to us. VS: BP 137/82, O2 SAT 99%, HR 89 minute. Vitals at 10 minutes post symptoms/Benadryl BP 160/89, P 82/min, O2 SAT 100%, 15 minutes post symptoms/Benadryl BP 139/91, P 81/min, O2 SAT 99% No symptoms per staff member's verbal statement. She returned to work.

Patient experienced numbness and tingling in throat.Onsite EMS was called Patient treated, Left aginst medical advice. BP 126/74 100% O2 HR 88

10 minutes after the vaccine was administered, the patient started presenting a tingling sensation on her throat. She was given diphenhydramine 50 mg IM.

41 yo female received second dose of Moderna COVID-19 vaccine on 1/26 @1747. Approximately 15 minutes after time of administration, patient had s/s of tongue swelling and dryness as well as an anterior chest wall erythematous rash. No airway involvement based on assessment by physician. Reaction was treated with diphenhydramine 25 mg, famotidine 20 mg, and IM epinephrine 0.3 mg. Patient transported to ED. Improvement noted: "slightly swollen tongue, but had no SOB/dyspnea". Given prednisone 40 mg. Observed for 4 hours. @2214 symptoms were completely resolved and patient discharged with EpiPen prescription and allergy referral. Patient advised to avoid current mRNA-type vaccines should subsequent "booster" doses of..

Onset of ringing to R ear 30min post vaccination. Developing into tinnitus R ear, dizziness with motion over next 24 hrs. Significant hearing deficient on 2/12 on R ear. PCP seen on 2/15, identified normal auditory exam, high dose predisone started. ENT/Audiologist scheduled 2/16 - diagnosed neuro hearing loss to R ear, not related to covid virus or etiology with normal eardrum mechanics, recommended continue steroid taper x3 weeks. Next audiology appt 3/9 for re-eval. Unknown disability or permanent damage at this time.

In post-vaccination waiting area 10 minutes after receiving vaccine, patient began scratching arm and started getting red appearance. Patient complained not feeling well and began turning redder 10 minutes later and began to complain of swelling tongue. Was given a 0.3 mg injection of epinephrine in right leg. Ambulance was called and patient was taken to Medical Center approximately 15 minutes later.

Headache, feverish (chills, sweats, aches), soar throat, clogged ears, inflammation of left arm including shoulder (left hand most recent bout of CRPS), nauseous, extreme fatigue. Ibuprofen 800 mg which isn't helping

Within 15 minutes post vaccine, complained of "scratchy throat". HR 80 Resp 16 BP 130/90 Complained of tingling lips and hands. color pink/flushed. Agreed to transport to ER. In ER, further hyperventilating and developed wheeze. EpiPen given. In ER given benedryl and discharged within 3 hours with prednisone prescription. On 02/26, denies any symptoms

A few hours after the shot my arm hurt. Felt ok, otherwise, until about 20hrs after about. The right side of my face tingled and was a little numb and red; including part of my tongue, my check, and up my temple. Tingling subsided after a few hours. Then about 30 hours after the shot, a few hours after the tingle, the right side of my face got really hot, red, and slowly started to swell. It felt a little numb, including part of my tongue. I took benadryl, went to sleep, and woke up fine. I had a cousin and aunt with similar symptoms after their second moderna shot, I don't have their specific symptoms, but I do know their faces tingled, one 40 hours later the other a couple hours after the shot.

i kept thinking my lip was swollen last night then when i woke up this morning half of my face is not working. classic bells palsy symptoms. called the dr and we are resarching steroids with the vaccine.

Information provided by patient as follows. It does not appear patient was seen by a provider in the clinic or emergency room. Besides normal side affects of fever, sore arm, nausea, diarrhea, I have been very itchy and had a rash on the back of both of my thighs as well as all around my belly and head. Also I have been experiencing small spurts of lock jaw and pain in my skull behind my ears.

excruciating headache front and back of head, fever 102.4, body aches, fatigue, weakness, nausea, inability to focus

Severe sore throat, burning in throat, trouble swallowing, loss of voice, pain in and around neck, radiating pain to ears. Oral steroids, nebulizer treatments and benedryl every 4 hours. Still no relief.

Two days after vaccination, pt was driving to work and developed a severe headache, heard the sound of "nails" being shaken in her head, and "shocking" sensation in her head (from shoulders up to top of head). The sound as well as the shock sensation occurred frequently, every 10 seconds, and caused severe pain. She had CT brain as well as MRI of brain done = both were normal. Treated with 100mg carbamazepine BID (for possible trigeminal neuralgia) and symptoms resolved completely within 4 days of treatment.

Developed herpes simplex around mouth after dose 1 and dose 2. Both incidents happened 1 week after each injection. Very painful. In addition, several canker sores in mouth after both injections as well.

41 yo Female developed numbness and tingling in the tongue and mouth about 15 minutes after receiving 1st dose of Moderna vaccine. She reported a history of anaphylaxis to shellfish in the past and was being observed for 30 minutes. Member was brought over to care area to be monitored closer. After about 10 minutes, she reported progression of her symptoms with itchy throat and worsening tongue tingling. Exam and vitals remained normal. Based on her history and progression, team was concerned for early anaphylaxis. She was given an epipen shot and within 5 minutes all symptoms had resolved.

? Ears ringing ? Dizziness ? Could not stand up ? Started 2 minutes after receiving vaccination ? Going on 4 minutes ? Will call 911 if does not resolve by 10 min total ? Ambulance offered to patient ? refused for now ? Pt reports never having had a reaction to a vaccine in the past ? Mother is shopping, will drive patient home ? At 10 min, patient reports that she is feeling better while remaining sitting, and that ringing in ears is still noticeable, but markedly decreased in volume ? Pt is able to stand up and reports that she is no longer dizzy and able to walk ? Driven home by Mother

Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Flushed / Sweating-Severe, Additional Details: h/o anaphylaxis to flu shot, allergist recommended receiving COVID vax, preferably Moderna. Came prepared w/ benadryl, EpiPen, water. Pt stated she was aware and consenting to receiving vaccine. We advised for her to sit in the observation for at least 30 minutes. After receiving vaccine, she began getting red and itchy at the neck, traveled to arms and up to face. Trunk and upwards red and itching. Gave 2 benadryl at beginning of rxn, +1 as it worsened &called EMS - pt refused care

The patient had tightness in the throat. Then her lips started to tingle and her face looked red and swollen.

Slight swelling of the back of the throat and tongue. I waited 30 minutes and was able to leave to take a Benadryl for the swelling. 15 minutes later I coughed a couple of times and then felt my throat constrict and had a hard time swallowing. My breathing became labored so I used my emergency inhaler and while trying to use my inhaler I started coughing and could not stop. Hard coughing. I work at a school that has a nurse on site and she helped the front office stabilize me after 30 minutes of coughing and not being able to swallow well. My pulse ox got down to 90 with a pulse of 122. I had a rash covering my throat and chest. I did take a Benadryl as well. An ambulance was called but by the time they got there the coughing was slowing down and my throat was opening back up. I was sent home to rest.

Approximately two minutes after I received the vaccine I had a strange feeling in my right arm (where I received the injection) that went away after about 30 seconds. About two minutes after that, I developed a bitter taste on my tongue that later spread to the rest of my mouth. Several minutes later, my lips began to tingle and swell, then my mouth (i.e. my soft palette) began to swell as well. About forty minutes after I received the vaccine, I began developing shortness of breath and spiked a fever. The on-site doctor administered an Epipen and I was transported to the ER. While at the hospital I had a blood drawn, a COVID test, a chest X-ray, and multiple EKGs performed. I was discharged about 2.5 hours later.

Next morning and continued still chemical taste in mouth, nothing tastes good. Taste like chemicals or metal in my mouth. Altered taste

About 45 minutes after receiving my vaccine I started feeling a tightness in my throat. I then became lightheaded and shakey. I was driving so I pulled over and called 911 who transported me to Hospital. The tightness and pressure moved down to my upper chest area also and my hands were tingling. I was given benadryl, pepcid and prednisone at the ER. About 30 minutes later I was feeling much better except for a scratchy throat. I was sent home where I slept the majority of the rest of the day. The next day I woke up with a very sore arm, very tired and a headache. Today the injection site is still a little sore and I have a headache.

Moderna COVID-19 Vaccine - Tingling in lips, cheeks, and forehead. Symptom resolved itself after approx 8 hrs.

patient had redness and swelling at the injection site the evening after she got the vaccine, then experienced muscle aches, nausea, SOB, fatigue, headache, and loss of smell over the weekend. Reported feeling much better Monday 3/8/21, but still nauseous and had no sense of smell

PT C/O WARM SENSATION IN HER THROAT, THAT SLOWLY DISSIPATED AND A MEDICINE LIKE TASTE IN HER MOUTH . BP 138/92 HR 92 SpO2 98%

I?ve experienced severe allergic reactions to many things. I?m now allergic to soy, yeast, wheat, coffee, casein (dairy) peanuts, green beans/ legumes, eggs, onion and celery. I?ve had a huge rash that broke out on my left arm that started at the spot where I received the injection. Now I?ve been experiencing my mouth and tongue swelling to the point that my throat has closed up. I?ve been hospitalized as air wasn?t going through my body. I had to inject an Epi-pen in my leg, and be taken to the hospital. I?m currently on high dosage prednisone, Benadryl and several other meds to address the swelling in my tongue that happens daily. I am desperate to find out if there is anyway to stabilize anything that vaccine had in it to see if this condition will get better.

1. 3/13 @230pm fever 101.6, took Tylenol and temperature went to 99.7 by 430pm. Have been cold (chills) since having the vaccine on Friday, though not feverish throughout. 2. 3/14 @ 0830am red and raised rash from above shoulder mid upper arm, raised higher at injection site 3. 3/14 @ 0515pm lower lip (left side) swollen, red and numb. Sore inside roof of mouth (left upper). Tongue slightly swollen, but not hindering breathing.

Approx. 15 mins after vaccination while client was being observed client reported redness up arms bilateral, discomfort and anxiety. Client moved to private room and Benadryl was administered and EMS called. Approx. 5 mins after Benadryl, client reported Hives to lower extremities bilaterally and numbness of the tongue. EMS arrived and transported client to nearest ER. No swelling or airway obstruction noted.

Got the shot Friday March 5th. Sore arm and muscle aches like the first dose on 2/5. Woke up March 7th with swollen lips/throat/tongue. went to urgent care and received an EpiPen and steroid. Monitored for a couple of hrs and went home for a nap. (refused the ER at this time as I felt better). Woke up around 2:30 and my symptoms worsened . We to ER and received another Epipen for anaphylactic shock. Remained at the hospital for 5 days. Had 5 episodes while there. Also, had tightening in chest and what felt like a heart attack. Been resting, still very tired and swollen nodes in my neck and sore throat as well as aches. Also, might be developing thrush. Didn't run a fever and Ive never had an allergic reaction before this.

Anaphylaxis. Initially, pt experienced palpitations and tightness in throat after vaccination and wasn't sure if she was experiencing swelling in her arms. BP was 130/79 and HR 93 initially. Pt started to feel better without intervention but given diphenhydramine as a precaution while we continued to monitor her. 10 mins later she started to have tingling in lips and tongue and visible lip swelling in addition to palpitations. Immediately administered Epipen (0.3mg) x 1. EMS was called. No worsening but not improvement after 5 mins so a second dose of Epipen (0.3mg) was administered. By the time EMS arrived (9 mins after first epipen dose) pt was feeling better, swelling had resolved, no throat tightness. Pt was transported to local hospital by EMS for monitoring.

swollen tongue (20 minutes after, subsided after taking allergy medicine) chills, headache, body aches, tiredness (lasted 4-5 hours, some symptoms improved after taking Ibuprofen) sore arm near injection (immediately and lasting 3 days) Was within 90 days of testing positive from COVID (January 2, 2021 was positive test)

PT BECAME HYPOTENSIVE, DIZZY. BP: 90/62, HR WEAK 58-60. HYDRATED WITH WATER 16 OZ, LYING SUPINE. AFTER 10 MINUES, BP 110/60. COLOR RETURNED. DIZZINESS GONE. SENT HOME

Numbness in lips and tongue, tingling and numbness in right arm and 3rd and 4th fingers on both hands, raised blood pressure, broke out in hives all over body. Two weeks later and still no feeling in tips of fingers

Moderna COVID-19 Vaccine EUA Few minutes after receiving the vaccine, felt slight nausea and light-headed. Very soon after the vision went blurry. Takes about 3-4 seconds to refocus. Vision becomes blurry again when glancing around. Did not inform pharmacist and learned how to refocus. The second day the blurriness is still there but takes only half a second to refocus each time. By third day vision is back to normal.

After approximately 5 minutes after receiving Dose 1 of Moderna Vaccine patient complained of metallic taste in mouth, dizziness, and increased heart rate. Patient sat down in chair. Pharmacist called 9-1-1. Patient complained of swelling of throat. Paramedics evaluated patient for hives, took vitals, and evaluated patient. Patient was ok, but still complained of swelling in her throat. Paramedics told patient to take Benadryl to decrease swelling. Patient refused to go to hospital.

CONGESTION, EAR FULLNESS, SINUS PRESSURE, NOSE BLEEDS- NOTED ON 03/05/2021 PATIENT ACCEPTED ADMINISTRATION OF ANTIBODY INFUSION.

3/13: fever and chills; ibuprofen taken 8pm 3/14: 12:30am: fever and chills, acetaminophen PO 5am: fever and chills, acetaminophen PO low back pain, flank pain, hip pain, fatigue, dyspepsia, no appetite all day, Tylenol q4h highest temperature 100.9 3/15: fever and chills till 12pm, dyspepsia, no appetite, mouth sore, bleeding gums, fatigue 3/16: dyspepsia, no appetite, headache, vaginal inflammation with white patches 3/17: dyspepsia, no appetite, headache, vaginal inflammation with white patches 3/18: dyspepsia, no appetite, headache, vaginal inflammation resolved

12:45 patient received vaccine 12:55 patient felt "fullness" on one side of her throat then "fullness" on the other side as well; dizziness and nausea 13:50 EMS administered benadryl 50mg 14:10 patient felt no improvement, and was transported to Hospital

Fever, chills, body aches, shortness of breath, fatigue, nausea, dizziness, sore arm, runny nose, food tasted funny/off by 8pm on 3/6. Fever lasted almost 3 days. Shortness of breath was gone on the second day, chills and body aches lasted until the fever was gone. Nausea and dizziness lasted a week. Red, raised, blotchy, itchy patch on arm around injection site arrived within a day. On the evening of 3/16/21 a red, raised, blotchy, itchy rash began on my legs and by 3/17/21 had spread up my legs, buttocks, back and small blotches began forming on my arms before I took Benedryl which calmed down the reaction. It is 3/18/21 and I am still fatigued, especially at the end of the day.

Sore arm all day. Woke up at 1am extremely nauseated, headache, and in sweats. Went to kitchen to get some nausea meds and felt my ears closing. I couldn?t breathe and apparently passed out. My husband called 911 and I came in and out for about 30 min he said. I couldn?t open my eyes and couldn?t feel my legs. Bp was normal and so was blood glucose. They gave me some fluids and nausea meds and I started coming too. Today I am extremely achy and terrible headache, scared to get out of bed.

Moderna COVID-19 Vaccine EUA. Fever, aches/pains, ear ache and vertigo, stuffy nose, injection site pain

Pt had anaphylactic reaction including throat, mouth swelling and SOB, administered Epinephrine 0.3mg, sent patient to ER via ambulance.

Received the vaccine at 12:35pm and at 12:44pm noticed a hive on my neck and a mild rash across the top part of my chest. I felt a flushing sensation and started to notice some difference when swallowing. Within a few minutes my lips began to tingle. After getting some fresh air and sitting with the EMS my symptoms were starting to improve but not resolved. I was given a dose of Benadryl (pill form) and within 15 minutes all symptoms started to improve. Within 30 minutes all symptoms resolved. Total time, I spent about 45-50 minutes before leaving the station. I would also like to note that when I was given the injection I did experience some bleeding, which seemed a little more than normal. It was ok within a minute or two. Since, I have a small bruise where the injection was given.

March 5th left side of face started twitching lasted all weekend. Headaches, arm pains, chest pains, tingling of toes and hands, numbness of tip of tongue started March 8th, 2021. Currently 3/21/2021 my face is tingling continuously with small twitches from time to time. Headaches off and on lasting about 4 hours. My right eye hurts, feels like electrical shocks to my head and scalp of my head periodically.

Waves of metalic taste in my mouth on the second dose. On the first dose I had a VERY strong metallic mucus tasted for about 3 days and nausea. After the second dose all my muscles seized up and I had fever, chills, overnight sweats, I had waves of nausea and a terrible headache. I am still nauseous 2 weeks later. I am taking anti nausea meds and drinking ginger teas. Any injury I have ever had like broken bones or torn rotator cuffs have all started hurting so incredibly bad. I also had a COPD flare up.

Tingling began on left side of face around 12:45 pm, 15 minutes after shot (in left arm). Tingling spread across forehead and down left side of cheek and jaw. Over the next 5 minutes tingling turned to burning sensation and left eye began to burn. Around 1:00 pm 3/4 of face and both eyes were burning but not painful and cheeks and forehead were slightly numb. Approximately 45 minutes after injection my tongue began to tingle and burn. No swelling. Around 1:45 on my left upper thigh also began tingling and burning. By 3 pm all symptoms were gone.

5 min after vaccine administration the entire right arm tingled. That faded within 2 min, at which point the tongue started tingling on both sides. At 18 min post-vaccine, patient spoke to pharmacist and was advised the tongue tingling was not an expected or documented side effect; the pharmacist requested that the patient stay an additional 5 min for monitoring. During that 5 min, a mild rash appeared on both forearms and tops of both hands. Pharmacist advised patient to take bendaryl and monitor for any further adverse symptoms. When patient reached vehicle, she noticed that her face was bright red and rash had appeared on part of neck and chest. Benadryl was taken at roughly 55 min post-vaccine. 1.5 hrs post vaccine, patient noted some of the rash had disappeared, the face tingling had stopped, and the tongue was less tingly.

Patient was given her first dose of the Moderna vaccine 3/24/21. Patient was directed to the observation room for monitoring and asked to wait 30min due to anaphylaxis allergy to peanuts and angioedema reaction to shellfish. Pt explained her throat was "scratchy" and "feeling funny, like I ate something I wasn't supposed to." Pt was alert and oriented. Denied SOB/chest pain. Reports slight wheezing. Vitals WNL-see below. ED rapid response was called. Vitals @ 0900 BP 110/80 HR 96 O2 sat 96% on room air Patient declined receiving epinephrine pens and requested diphenhydramine which she received when she was taken to ED for observation. Patient was discharged an hour later

Swelling to the entire right side of my face, including eye lid being nearly swollen shut and watering profusely. Swelling subsided around 5 hours later after taking Benadryl

Very swollen Eyelids 3/22-resolved. Hives on face, neck, ears, elbows, knees, gluteal muscles 3/23-current, worse on right side of body. Antihistamine (azelastine) administered and beneficial. Throbbing, sever intermintant Rt side temporal headache 3/22-current. Slight dizziness

After 10 minutes from the Moderna Vaccine, experience Tachycardia of the Heart, heart rate reach 160. Increase of blood pressure, numbness is lips, and numbness of the right cheek. Was rushed by Ambulance from Vaccination site to Hospital

30 minutes after shot, numbness and tingling up left side face and shoulder, including tongue. No swelling except at vaccine site. Did not get worse. Resolved completely in a few days. Doctor took note but said I should still get second shot next month. 1 week post vaccine, swelling and itching at site.

Pt reported a bad taste in her mouth after receiving the 1st dose of COVID vaccine. She drank water and sx improved, but then returned. She then reported chest pressure, left side. She refused further eval in the local ED.

Within 15 minutes: Dizziness, light headed, seeing stars, blurred vision, racing heart rate. I thought at the time I was having a panic attack. I tried to slow my breathing and relax. It did not help any. I monitored my Heart rate on my watch. My EKG said my heart rate was high and marked 138 at one point while at rest when my average resting rate is 52. By the time I walked to my car I felt chest pain and pain in my neck. It was a tightening and burning. In my car, at 1:25 I took antihistamine in a 24 hr dose of Claritin and an inhalation of OTC Flonase. I felt my body calming slightly, but not 100% returning to normal. I alerted my Dr. and she agreed I should not have the second dose without first taking an otc antihistamine and also having an epi pen on hand. I stayed with a friend so I was not alone, and continued to rest. At 6:12 i tried to move around and my hear rate shot back up to 132. I sat back down. At 9:30 I still have pain like I?ve been punched really hard in the chest.

Initial side effects included fatigue, intermittent chills and fever (unmeasured), severe body aches, and injection site pain and soreness. On day 4, the chills and injection site complaints were gone. On the night of day 4, I developed a dry cough and throat irritation. On day 5, my body aches were gone, but I had a low-grade fever all day and developed hives-like spots throughout my body, although they were mild and did not itch. I lost my appetite. Fatigue lessoned to tiredness, but the dry cough and throat irritation worsened. On day 6, my body temperature normalized, at least for the most part. My cough and throat irritation continued to worsen, and I received a positive COVID-19 antigen test result. (My PCR test result was negative.) On the night of day 6, I developed chest discomfort. On day 7, my symptoms continued, and I also had taste disturbances with certain foods. On day 9, my appetite improved a little bit, but additional hives-like spots developed. On day 9, I also re-tested for COVID-19. Both my antigen and PCR results were negative. On day 10, my dry cough, throat irritation, and chest discomfort began to fractionally improve, but I suffered some mild body aches again. Today, on day 12, I am still suffering from a dry cough, throat irritation, and chest discomfort, with decreased appetite.

Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: hives, mouth dry, lightheaded, throat itching, chest tightness. Assessment : Time of assessment 1035. Actions taken: Patient was placed in a wheelchair, taken to the triage area. She had hives to her arms, behind her neck and ears. She was flushed in the face. BP 138/91, P 135 initially, last BP 132/91, P 116. Medications administered: 1039 Benadryl 50 mg IM to RD given; 1047-Solumedrol 125 mg IV given via 20 G Saline Lock Left AC all by EMS. Disposition: Hospital via Ambulance Patient's symptoms of rash improved, she still had itching of her throat and chest tightness with no audible wheezing after medications given and when ambulance arrived.

At 2:00 pm pain on top of hand radiating through fingers. Patient's joints hurt. Lasted 5 minutes and went away. Pain scale 3 out of 10. At 2:30 pm face and tongue started to feel sort of numb and swollen, but no swelling existed. The sensation intensified over the next hour (around 3:30 pm), at the most it felt like "shots of novocaine given" and that the feeling was starting to wear off in cheek, tongue and lip areas. Patient states if took about a total of 8 hours for sensations to wear off. Patient also reports feeling tired.

Never seen anyone bleed this much; Numbness in her fingertips and toes; Tingling in finguretips and toes; Throat closed up; Eyes swollen; Swollen itchy hives; Felt a little dizzy; Discoloration in her skin pattern; Full body rash head to toes; Rash; Swollen itchy hives; Ungodly itch open sores; Hives so large and severe; Low grade fever; Headache; Vomiting; Diarrhea; They were able to stop her from going into anaphylactic shock; A spontaneous report was received from a consumer concerning 41-year old, female patient who received Moderna's covid-19 vaccine (mRNA-1273) and developed felt a little dizzy, diarrhoea, vomiting, headache, low grade fever, full body rash head to toes, hives so large and severe, throat closed up, eyes swollen, discoloration in her skin pattern, numbness in her fingertips and toes, tingling in fingertips and toes, swollen itchy hives, ungodly itch open sores, rash and never seen anyone bleed this much, they were able to stop her going into anaphylactic shock The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included tumeric, multivitamin, vitamin d, lexapro and adderall. On 22 Jan 2021, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mrna-1273 (batch number: 039k20a) intramuscularly in the left deltoid for prophylaxis of covid-19 infection. On 23 Jan 2021 the patient had experienced felt a little dizzy, diarrhoea, vomiting, headache, low grade fever, full body rash head to toes, hives so large and severe, throat closed up, eyes swollen, discoloration in her skin pattern, numbness in her fingertips and toes, tingling in fingertips and toes, swollen itchy hives, swollen itchy hives, ungodly itch open sores, rash and never seen anyone bleed this much and they were able to stop her going into anaphylactic shock. Treatment for the event included was given steroids, benadryl, and prescription antihistamine. Action taken with mrna-1273 in response to the events was not provided. The outcome of the events were not reported.; Reporter's Comments: This case concerns a 41 Y/O F with serious unexpected dizziness, urticaria, diarrhea, vomiting, pharyngitis, eye swelling, skin discoloration, hypoesthesia, paresthesia, pruritus, swelling, rash, hemorrhage, pyrexia, headache. Event onset Day 2 after first dose mRNA-1273. Treatment prevented anaphylactic shock. Event outcomes unknown. Based on current available information and temporal association between use of the product and start date of the event, a causal relationship cannot be excluded.

On 2/25/21 I received my first Moderna vaccine. Later that day, I started to experience some brain fog and fatigue. this resolved itself after approximately 4 hours. On 3/3/21 I took my dose of Humira that I use for Crohn's Disease and about 3 hours later experienced extreme fatigue. I have been on Humira for 3.5 years and I have never experienced a reaction to the Humira like this. On 3/4/21, the next day after taking my Humira, I once again experienced extreme fatigue, a very bad headache and horrible brain fog to the point where the things I was reading on my computer and things people were saying to me was not making sense. I was also very nauseated and had severe diarrhea. I was tested for Covid just to be sure and I was negative. I went home and fell asleep and slept for 6 hours. I did feel better upon waking up. Approximately one week later I experienced a sever migraine with visual disturbances. On 3/15/21 I began having a Crohn's flare. I had been in remission for 3.5 years with my last colonoscopy in October of 2019 showing this and that my Crohn's ulcers had improved. I went to the ER on 3/16/21 in severe pain, was found to be in a flare with inflammation and swelling in my small intestine and a partial blockage. I was admitted to the hospital for 2 days where I received IV steroids and fluids. I was sent home on oral prednisone and now have to add additional medication to my Humira regimen for my Crohn's. I am sure that some will say that none of this is related to the Moderna vaccine I received, but I have had no issues with my Crohn's in 3.5 years until I had this vaccine. All of my issues this past month coincide with receiving the vaccine and I have never had any side effects whatsoever from the Humira. In fact, it's always made me feel better when I've been due to take it, so I know that my symptoms are not from the Humira. I cannot say for sure if the vaccine caused my issues, however, it's pretty coincidental that I was feeling good and otherwise healthy until I had this vaccine.

This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain), CHEST DISCOMFORT (Chest Tightness), LIP SWELLING (Swollen Lips) and ADVERSE REACTION (allergic reaction to the vaccine) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PAIN (Body Aches) and PYREXIA (fever). On 06-Mar-2021, the patient experienced CHILLS (Chills). On 15-Mar-2021, the patient experienced PRURITUS (Itchiness), ERYTHEMA (Redness) and URTICARIA (Hives). On 20-Mar-2021, the patient experienced CHEST PAIN (Chest Pain) (seriousness criterion hospitalization), CHEST DISCOMFORT (Chest Tightness) (seriousness criterion hospitalization) and LIP SWELLING (Swollen Lips) (seriousness criterion hospitalization). On an unknown date, the patient experienced ADVERSE REACTION (allergic reaction to the vaccine) (seriousness criterion hospitalization). The patient was hospitalized on 20-Mar-2021 due to ADVERSE REACTION, CHEST DISCOMFORT, CHEST PAIN and LIP SWELLING. At the time of the report, CHEST PAIN (Chest Pain), CHEST DISCOMFORT (Chest Tightness), LIP SWELLING (Swollen Lips), PAIN (Body Aches), PRURITUS (Itchiness), ERYTHEMA (Redness), URTICARIA (Hives), ADVERSE REACTION (allergic reaction to the vaccine), PYREXIA (fever) and CHILLS (Chills) outcome was unknown. Following the first dose of the vaccine, the patient experienced fever, chills and body aches that lasted for 24-36 hours and then subsided. Following the second dose of the vaccine, the patient initially experienced the similar side effects of fever, chills and body aches that lasted for a similar time frame. Then, on 15 Mar 2021, the patient began to have full body itchiness. No rash was present, but wherever she would itch would turn red and break out into hives. This continued and then on 20 Mar 2021, the patient was taken to the Emergency Room because she experienced tightness in her chest, chest pains and swelling in her lips. There she was treated for an allergic reaction to the vaccine. Some symptoms have improved but all are still present at the time of the report. Treatment details included Pepcid, Claritin D, Mailax, Prednisone, and Benadryl.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient is a 41 yoF that was transferred to Medical Center on 4/10/21 after being seen at a free-standing Emergency Department for chest tightness and shortness of breath worsening over the past week. Pt reportedly received both COVID-19 Moderna vaccines (1/24/21 and 2/26/21). Over two weeks prior to admission she was exposed to her brother who was found to be COVID19 positive. The patient stated that her symptoms started 3/30/21 and she was found to be both COVID19 and influenza positive on 4/2/21 prior to admission. She did not take COVID precautions when she was exposed to her brother. Her symptoms started with fever, chills, myalgias, fatigue, nausea, vomiting, and loss of taste/smell. She also reported her pulse ox revealed O2 sats at 88%. She was admitted to the hospital 4/10/21 and later discharged on 4/15/21. She was given supplemental oxygen, Remdesivir, Dexamethasone, and convalescent plasma while being admitted.

Broken blood vessels in left eye; Slight face numbness; Ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVAL HAEMORRHAGE (Broken blood vessels in left eye) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE for Thyroid disorder, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication. On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced TINNITUS (Ringing in ears). On 20-Apr-2021, the patient experienced HYPOAESTHESIA (Slight face numbness). On 21-Apr-2021, the patient experienced CONJUNCTIVAL HAEMORRHAGE (Broken blood vessels in left eye) (seriousness criterion medically significant). At the time of the report, CONJUNCTIVAL HAEMORRHAGE (Broken blood vessels in left eye) and HYPOAESTHESIA (Slight face numbness) outcome was unknown and TINNITUS (Ringing in ears) had not resolved. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided. Company comment:This case concerns a 41-year-old female with a serious unexpected event of conjunctival hemorrhage, and nonserious unexpected hypoaesthesia and ongoing tinnitus. Event onset the same day as second dose mRNA-1273. Event outcomes unknown. Tinnitus ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-083153 (E2B Linked Report).; Sender's Comments: This case concerns a 41-year-old female with a serious unexpected event of conjunctival hemorrhage, and nonserious unexpected hypoaesthesia and ongoing tinnitus. Event onset the same day as second dose mRNA-1273. Event outcomes unknown. Tinnitus ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD-2021-083153:CROSS LINKED WITH DOSE 1

Pt with c/o extreme nausea and metal taste in her mouth. Received 1000ml bolus of NS IV (11:13am). Solu-Medrol 125mg IV (11:13am), Zofran 4mg IV (11:13am) and Compazin 10mg IV (15.44pm).

Shortly after leaving vaccine site tingling, slight numbness to left side of ace, and left feeling "cold".. Cheek flushed, tingling and numbness. numbness to tongue. Facial flushing resolved within 1 hour. Numbness-tingling resolved by morning of next day.

Within 5 minutes tongue began to go numb, a few minutes later cheeks and mouth went numb, heart rate was 115 white sitting down, blood pressure was 115/60 (typical blood pressure is 120/75), felt lightheaded and "out of body." Instructed to take Benadryl or have facility call an ambulance. Waited at site for nearly an hour for symptoms to improve, lightheadedness and out of body feeling improved, left site, took a 10 mg dose of liquid Benadryl at about 3:10, tongue and facial numbness went away about 4:30 pm same day.

Tongue swelling after receiving COVID-19 vaccine. No difficulty breathing, no rash. Claims posterior aspect of tongue is swelling and causing her a gagging feeling. No chest pain.

30 minutes after vaccination: numbed left side of face Around 4 pm started with ringing ears, lightheaded . Light chest pain but not too bad to go to the ER.

Patient took ibuprofen, 2 zyrtec, 2 pepcid and ubrelvy that morningat 7am. Injection was administered at 9:30am, reaction started at 09:45am increased phelgm, severe migraine, tightness in chest, tongue swelling face swelling, patient took 4 zyrtec, 4 pepcid, ubrelvy. By 4pm tightness of chest and increased mucus subsides. That evening patient took 2 zyrtec 2 pepcid, 2 benadryl that evening, continued to have severe migraines, face and tongue swelling until 1/5/2021.

Couldn?t move head/neck without moderate to severe pain, lymph nodes on affected side where injection was give were hard and extremely painful to palpate. Neck and jaw pain day three extremely bad migraine causing me to miss work

usual adverse reactions included body aches, chills, low grade temp (below 100.0F)runny nose, head congestion. Around 8:30pm, eyes began watering and burning, migraine type pain on left side of head began. At 6am January 7, 2020 left side of face was swollen and sensitivity to light present, pressure and discomfort only on that side of face. Eye swollen and continuously watering.

Employee was being observed right after vaccine and B/P 146/104, started having left sided head, neck, ear, jaw throbbing pain and a headache, then pain went into left groin area-employee stated, "It's like I can feel it moving all through my lymphatic system. Then after about another 5 minutes employee became lightheaded and "fainty" like feeling and then was nauseated with continued left sided pain as listed above. After about 10 minutes B/P 146/116, employee was transported to the emergency department for further evaluation. 2nd day-12/30/2020-employee had body aches all over, extreme fatigue and headache. 3rd day-12/31/2020-employee was just tired and fatigued. 4th day-1/1/2021-employee had no symptoms and felt much better.

Arm and facial swelling, metallic taste in mouth, dizzy and lightheaded within a few minutes after vaccine. Benadryl 50mg IM given then taken to the ED for further evaluation and treatment

nitial Encounter: Per patient, she has had allergic reaction to sulfa drugs. When she took sulfa medication, she developed hives and tongue swelling. She denies having any respiratory or anaphylactic reactions. Patient denies wanting to speak to her provider about getting the vaccine and has consented to get the vaccine today. Patient is aware that she will be monitored for 30 minutes by nurse. 16:22: Patient is currently complaining of tongue tingling and concerns for tongue swelling. Patient escorted to room 11 with resource RN available. 1624: Patient brought back to Obs room 11 for complaint of tingling to tongue. On assessment Patient was alert and oriented, Sat probe placed and BP cuff, observed patient to have redness to chest and that continued to worsen as BP cuff placed. Clear to all lobes, no increased WOB. Per patient tongue felt tingley, no swelling observed to tongue, lips or face. VS obtained at 1624: HR 124, RR: 16, Pox: %99, BP: 159/102 tp Lt arm. Pt developed redness to Lt arm from elbow down to wrist. VS obtained again, HR: 114, RR: 16, Pox: %99, BP: unable to obtain as patient was moving arm. Patient began complaining of increased itchiness in mouth and "lip swelling", writer and PCT both observed swelling to patient upper lip. Instructed nurse to call 911, called back to Obs rm 11to assist. Epi pen administered to Rt quadricep at 1633, VS reassessed; HR: 116, RR: 16, Pox: %99, BP: 169/107 (126) Rt arm. Redness to Lt arm, chest and neck began to resolve and swelling to upper lip began to resolve, clear to all lobes. Doctor arrived to Obs rm 11 and was updated on events. Patient remained alert throughout. Patient's daughter notified via teams and was able to call and speak with her mom. EMS arrived and care transferred. Per EMS patient was to be transferred to hospital. Patient left on EMS stretcher with personal belongings. Reporter by nurse.

Initial Encounter: Per patient, she has had allergic reaction to sulfa drugs. When she took sulfa medication, she developed hives and tongue swelling. She denies having any respiratory or anaphylactic reactions. patient denies wanting to speak to her provider about getting the vaccine and has consented to get the vaccine today. patient is aware that she will be monitored for 30 minutes. 16:22: Patient is currently complaining of tongue tingling and concerns for tongue swelling. Patient escorted to room 11 with resource RN available. 1624: EE brought back to Obs room 11 for complaint of tingling to tongue. On assessment EE was alert and oriented, Sat probe placed and BP cuff, observed EE to have redness to chest and that continued to worsen as BP cuff placed. Clear to all lobes, no increased WOB. Per EE tongue felt tingley, no swelling observed to tongue, lips or face. VS obtained at 1624: HR 124, RR: 16, Pox: %99, BP: 159/102 tp Lt arm. Pt developed redness to Lt arm from elbow down to wrist. VS obtained again, HR: 114, RR: 16, Pox: %99, BP: unable to obtain as EE was moving arm. EE began complaining of increased itchiness in mouth and "lip swelling", writer and PCT both observed swelling to EE upper lip. Instructed to call 911, RN called back to Obs rm 11to assist. Epi pen administered to Rt quadricep at 1633, VS reassessed; HR: 116, RR: 16, Pox: %99, BP: 169/107 (126) Rt arm. Redness to Lt arm, chest and neck began to resolve and swelling to upper lip began to resolve, clear to all lobes. Dr. arrived to Obs rm 11 and was updated on events. EE remained alert throughout. EE's daughter notified via teams and was able to call and speak with her mom. EMS arrived and care transferred. Per EMS EE was to be transferred to Parkland. EE left on EMS stretcher with personal belongings. ~RN

My right upper eye lid kept twitching for 5 minutes then it stopped. Then after 2 hours kept twitching for ten minutes then it stopped.

Dizziness, Headache, Myalgia, Tachypnea, CoughWheeze, NauseaVomiting, Palpitations & Tachycardia & Narrative: Patient stated that after receiving injection on 01/06/2021, tasted metal in her mouth. No reaction noted in clinic after vaccine administered. Patient states that after returning home, she began to have chills, headache, and muscle aches. Could not sleep. On 01/07/2021. Patient continued to experience above symptoms. Approx. 13:50 on 01/07/2021. Patient presented with respiratory difficult, tachypnea stridor, and stated she felt as if her airway was closing. Patient was vomiting and was tachycardic. Epi-pen administered via left lateral thigh. Patient administered 50mg of PO Benadryl, and 2 puffs of albuterol inhaler. Continuous V/S initiated. Patient began to experience relief of symptoms. HR and blood pressure remained elevated, but this was expected side effect of epi. SpO2 stabilized around 99% on room air. Patient was monitored for 60 minutes. Transportation home was arranged and family was present to observe overnight.

patient developed flushing and throat tightness after vaccine which quickly resolved, then repeat episode 30 minutes later, given 25mg PO Benadryl, observed another 30 minutes, eyes developed swelling was given Benadryl 25mg PO and sent to ER

A little over 24 hours post vaccination (09JAN2021), I started to experience some tongue numbness/tingling along the lateral edges and the tip of my tongue. This is ongoing as of time of this report. This is not interfering with function, but it is a new symptom that I did not have prior to receiving my vaccination. As additional medical history in the last 30 days, I had dental work done for a broken filling on 21DEC2020 (multiple numbing injections during this visit - two molars grounded down to prepare for placement of two crowns of left lower molars). 2 crowns placed on 06JAN2021 (1 numbing injection at this visit). Additionally, I also started with symptoms of inner ear infection on 03JAN2021, was evaluated by medical provider on 05JAN2021 and diagnosed with suspected inner ear infection, for which I am currently taking doxycycline and sudafed for.

Thursday night shortly after the vaccine I was exhausted and headed home to go lay down. While driving, I developed a severe headache. I went home and went to sleep really early. Friday morning, woke up, went to work. Extreme lethargy and severe headache. Left work early (2 ish) with joint pain, headache, lethargy. In the evening (still Friday) I went to the grocery store and walking in the parking lot to the store my joints hurt with every step. I sent my partner in and I went back to the car. I could not do it. Went to sleep soon thereafter. Saturday morning, we woke up and had planned to go to the cabin. We were trying to run errands (coffee shop, post office, bank...simple errands) and I was exhausted and feeling bad. Still headache, lethargy, achy. Assumed it was flu like which was a side effect, so I continued to press on through the discomfort. Left for the mountains. less than 1 mile from home, started to feel tingling and "buzzing" throughout my body, like a vibration sort of. Stayed quiet and thought about this. Another block or two and the feeling was in my tongue. Then I felt it in each tooth root and spoke up. I asked to go home and rest for 30 minutes before going to the cabin. At this point, I could not move my hands. We got to the house and I could not open my car door or take off my seatbelt. I had hand paralysis for about 10 minutes. Made it in the house. Got to the couch and laid down for about 60 seconds. Got up had to use the restroom. Solid, not diarrhea, but took 45 minutes. Apparently, I was pale like a piece of paper. I do not remember being in the bathroom for 45 minutes, I felt like it was 5 minutes, partner said 45 minutes. Made it back to couch, laid down, freezing! Under 2 blankets, one of them was an electric blanket on high. Began throwing up, clear bile. Had not eaten anything yet. Stayed on couch, also lost track of time, was there for 5 ish hours. Tried to eat something so I could take Tylenol for the headache. Barely ate anything, so I never took the Tylenol. It lessened. Cabin trip cancelled. Still lethargy and dizzy yesterday but no joint pain, no nausea. Now, Monday morning, still dizzy/lightheaded. Symptoms are subsiding, but not gone.

Started getting fever as high as 102.1, felt like me spine was crushed and I couldn't get up, massive headache with pressure in my eyes.

When I woke up on Dec 31 (the day after my shot), my face was swollen and my the area around my eyes was very swollen. I began taking Benedryl and continued to take Benedryl every 4-6 hours over approximately the next 48 hours. Also, I originally had no injection site reaction, however, on Jan 9th, my right arm began to itch. Upon assessment, I noted a 1.5" diameter red, warm area where the vaccine had been administered. This lasted for three days, and now, January 12th it no longer itches, and looks more like a bullseye that is approximately 2.5" in diameter around where the redness was. I have also noticed that since the vaccine I feel cloudy or like I have a constant mild headache.

after vaccine felt flush with throat tightness, quickly resolved then repeat episode at 30 minutes, given Benadryl 25mg PO and observed for another 30 minutes, at 4pm eyes were swollen, given another 25mg PO and paramedics were called, sent to Hospital.

Complain of itching (no hives) lip numbness, and throat tighning. Given 25mg benedryl po and 25mg Benedryl IM. Transferred to ED for eval at 0938. Discharged at 1053

numbness in tongue, bottom lip and chin. Lasted around 3.5 hours after taking a dose of OTC benadryl.

Warmth fling rush from shoulders up through neck to top of head Muffled hearing Felt faint Blood pressure drop

Patient came into Public Health Clinic for 1st dose of COVID-19 Vaccine. Patient completed COVID-19 vaccine screening checklist for contraindications. Patient reported that she had a penicillin allergy-hives and had a reaction to an unknown agent that caused eye and lip swelling. Form reviewed by Dr who verbally screened risks for patient. Patient made educated decision to get vaccine knowing risks of allergic response. Patient received Moderna Lot # O11J20A in left deltoid administered by Indigo RN. Patient observed in clinic for 15 minutes after vaccine given. No reactions reported at that time. Patient waited longer due to significant other also receiving the vaccine and having to wait for observation. At 1054 patient reported to pharmacist of her lips feeling tingly and her tongue feeling heavy. She reported to, RN and informed Dr. of patient's status. Upon physical assessment of oral mucosa, no tongue swelling, throat soreness, redness or swelling noted on physical exam, vessels under bottom lip looked slightly dilated. Patients lips also within normal limits, no swelling noted. Vital signs of 98.3F tympanic, O2 sats 100% on room air, heart rate 91, respiratory rate 16. BP R. arm 164/104, L. arm 165/112, manual on R. arm 164/98. Patient states she took hydrochlorothiazide for BP at 12:30, right before coming into clinic. Patient still feeling like her lips are tingly and tongue is heavy, Per Dr. would prefer to assess patient in the ER. Instructed patient to go to Health Center ER with husband for further assessment. Per chart review from ED, Pt monitored in ED for 1 hr. without recurrence or development of symptoms. She states that she feels normal and is ok with going home. Return precautions discussed. No interventions.

Moderna COVID?19 Vaccine EUA - had mild swelling of right eye about 30-45 min after injection - later that day had headache, fatigue and mild dizziness. For 24-48 hours after injection had nausea, fatigue, dizziness off and on - swelling of right eye about the same. 72 hours after injection noticed moderate swelling of both eyes, right worse than left and swelling of upper lip. Also had some numbness and tingling to upper palate and back of throat. Took 3 doses of benadryl that day and have continued to take zyrtec daily for 5 days - swelling has improved quite a bit but still noticed in right eye. Swelling of lip and numbness and tingling of throat resolved after 2-3 doses of benadryl.

about a half hour after the vaccine was given my mouth and tongue were numb for about an hour then it went away but came back for another hour or so and went away again and stayed gone.

Delayed adverse reaction day 9 (1/7/21) arm was itchy. By nighttime red bullseye type mark on arm. No response to OTC hydrocortisone. On Friday, Saturday, and Sunday I took over the counter day time allergy meds without much relief. Spot on arm continued growing nearly to elbow and was hot to touch. Sunday night switched to Benadryl. Itchy throughout entire body- tingly lips and nose, but no swelling to tongue.

Immediately after getting the vaccine, AP reported a feeling of tingling of her tongue. She denied any feeling of swelling. Spoke to her on 1/15/21, AP reports that the feeling only lasted for the 30 minute observation time that we kept her post-vaccination.

within 10 minutes of injection reported throat tingling and asked for diphenhydramine. reported she normally takes diphenydramine prior to influenza vaccination but did not share any previous reactions to influenza vaccination. observed x30 minutes with no further issues. BP WNL, no SOB, no swelling. at 30 minutes was informed that COVID vaccine did not have any components related to influenza vaccine and fell much better and discharged.

Night sweats, 12 hours after vaccination [lasted 12 hours] Swollen lymph glands right neck and right side of tongue (Very slow rate- no trouble breathing), 2 days after [lasted 4 days] Swollen left side of tongue (very slow- no trouble breathing), 3 days after [lasted 3 days] Brain fog & fatigue- difficulty focusing or moving more quickly, 2 days after [lasted 4 days] Muscle aches and chills, 5 days after [lasted 1.5 days] Swelling, itching, pain, redness & heat in left lateral upper arm just below injection site, increasing in size approx 2/3 daily- currently 7?x4?, 6 days after [currently taking place, 3 days so far]

Copper taste in mouth primarily on tongue. Started shortly after injection, resolved around 20 minutes later.

1/10Fatigue, 1/11 facial tingling to left side and eye brow area feeling heavy, 1/12 headache, 1/15 sore throat 1/16 left rib pain, wheezing, short of breath, fatigue 1/17 fatigue, chills, short of breath, wheeze, and loss of taste and smell. 1/18 I have a Telehealth visit with my Dr. Office at 12:40

Significant fatigue, loss of appetite, nausea, mild headache, dry eyes all within hours of vaccine. Symptoms continue after 7 days with only mild improvement.

Infection in left eye, possibly resulting in cellulitis in surrounding area, treated with erythromycin ointment and keflex oral antibiotic. Eye tenderness began evening of 1/10/21 and became severe by 1/12/21. I have never experienced such a severe eye infection before.

Severe headache Body aches Chills Fever of 106 F that would go down to 103 F with tylenol and ibuprophen Eye pain and burning Joint pain Severe fatigue Nausea Injection site intense sensitivity

Moderna covid vaccine EUA Fatigue, lethargy, headache, dizziness, nausea, diarrhea, abdominal pain, chills, sweats, muscles aches, injection site pain and swelling, visual disturbance Still having all symptoms with improvement

Symptoms began at 5-10 minutes after receiving vaccine: Started with lips feeling swollen and numb, no difficulty breathing, approximately 20 minutes after vaccine back of throat became itchy, Oxygen levels normal and no difficulty breathing, a little over 30 minutes after vaccine both cheeks became numb, a few minutes later on walking to the bathroom an irritating cough and throat clearing started. at 45 minutes after vaccine tongue became itchy, still stable oxygen levels and decision was made to go across the lobby to the hospital ER for treatment. On arrival to the ER there was a rash on the chest and by 4:20pm almost 2 hours after vaccine coughing fit with difficulty catching breath occurred, 18 gauge IV was placed in Right arm and IV benadryl 25mg and IV solumedrol 125mg was given with Albuterol inhaler 6 puffs delivered in a spacer. Symptoms began to resolve and almost gone within the hour of receipt of medications. Observation was continued for a total of 2 hours with Discharge by 7pm that evening. Discharge medication instructions were: Prednisone 50mg daily for 2 days starting Wednesday 1/20/21 and Benadryl 25mg every 6 hours round the clock for 5 days, Albuterol metered dose inhaler 2 puffs every 4-6 hours as needed in spacer (inhaler provided by ER) and Epic-pen to keep as needed for home in case of sudden onset reaction. By Wednesday 1/20/21 symptoms almost completely resolved except for occasional irritated cough and itchy throat and feeling flushed and tired from the Benadryl and a little jittery from the steroids..

About 8 minutes into my 15 minute observation time after receiving my first COVID vaccine, my tongue started tingling. The observation nurse gave be a Benadryl and water. within the next minutes my whole body started tingling, I felt nauseas, and felt like I was going to pass out. The nurse laid me on the ground. I asked her to take my BP and pulse. For me it was high 145/98. My pulse was also reported t be high. I was able to swallow and breath. I continued to have waves up and down my whole body of tingling, nasusea and cold sweats. The nurse called my husband to come. I was able to sit up after about 20 minutes. The waves of feeling sick continued for about an hour. After having some food and drink about 2 hours later I was able to drive home. I was exhausted, nauseous, and had a headache the next 2 days. I am concerned to get my second vaccine.

APPROXIMATELY 8 MINUTES AFTER RECEIVING MODERNA #2 VACCINATION, CLIENT DEVELOPED DIZZINESS, SHORTNESS OF AIR, PERIPHERAL TREMORS/NUMBNESS. CLIENT BECAME PALE AND DIAPHORETIC. CLIENT STILL ALERT AND ORIENTED X3. BENADRYL 25 MG ORAL GIVEN FOLLOWED IMMEDIATELY WITH EPI PEN ADULT DOSE @ 10:56 AM. VITAL SIGNS @ 10:54 WITH BP: 146/72, P: 131, REPIRATIONS 30, SKIN PALE/DIPHORETIC PRIOR TO ADMINISTRATION OF EPI. 2ND SET VITAL SIGNS @ 11:00 150/74, P: 119, R: 30 SKIN PINKINING/IMPROVING DIAPHORESIS STILL REPORTS PERIHERAL NUMBNESS/VISUAL PERIPHERAL TREMORS STILL PRESENT/REDUCED. 3RD SET VITAL @ 11:13 AM BP:136/68, P: 100, R: 26 REPORTS HER TONGUE FEELS THICK. TRANSFERRED TO ER FOR CONTINUATION OF CARE @ 11:20 AM VIA WHEEL CHAIR.

After vaccine injection today patient developed sluggish responses, unsteady gait, metaAllic taste, and "heavy head". Responses were delayed. Reports she was hospitalized in 2019 related to a flu vaccine reaction. Also reports she had an anaphylactic reaction to an allergy injection previously. Taken to exam room and assessed by CRNP. After 30 minutes patient complained of tingling in her lips and hives around her nose and mouth. Hives noted right side of nose and right side of mouth. Denies any increase sob. Initial vs 133/80, 88 O2sat100%. After 30 minutes vs 124/80 85 and O2sat 93%. Continued to deny increase sob. Reported her head was no longer "heavy". On advice of Provider, Patient was sent to ER for further evaluation.

Patient was in the observation area and soon after her vaccination, she started to feel warmth and tingling in the same arm that traveled to her left ear. She felt pressure in her ear which moved to the top of her head. Patient steadily improved while she was on scene.

Got the covid 19 vaccine January 19th (Tuedsay) at 1:00pm. Started having lip and eye swelling around 6pm and by 9pm she went to the ER after her throat started swelling and she was having difficulty breathing. Says the ER MD gave her a shot benadryl. Also got a prescription of prednisone 20mg 2 tablets daily for 5 days which she has been taking. Swelling resolved but then her eye started to swell last night as well as her lips so she went to the Instacare. Said the doctor told her to stop all her medications but the metformin. reports the last dose of humira was Sunday January 17th and she gets a dose every 3 weeks. Also had covid disease in November the week of Thanksgiving. Spanish speaker. Had an official translator for this infomation.

10 mins after receiving the vaccine, my right hand started to swell a bit and had pain in the wrist and I got the injection in my left arm. Them I went to urinate and it was painful that continued until this morning. My body became itchy all over my blood pressure was 184/107. I was having heart palpitations. I got queasy and didn't feel well. I was given benadryl and zolfran. My blood pressure went down to 151/92 after a bit then after an hour I was still itchy, blood pressure was 133/ 84 but then my throat left side tried to hurt and I Felt like something was stuck in my throat. I waited another 30 thirty mins and left. My left side of throat hurts a little and my left hand still hurts and a little itchy

I woke up with a throbbing eye that was burning. I had hives on my eyelid which was halfway swollen shut yesterday. Today the hives are still there but its not swollen shut, the throbbing is gone, the itching is gone its just the hives.

Swelling and thickening of the tongue and lips, irritation to the throat and roof of mouth. Benadryl administration on site and regime continued throughout the day at home. F/u with primary care 2 days later due to continued side effects of headache, stomach ache. Nausea and vomiting

Patient began to have itching on her legs, which spread to the rest of her body as a macular red rash, she received Epi 0.3mg, Prednisolone 45mg po, Benadryl 50mg po, Famotidine 40mg po. Patient was monitored with BP, HR, RR, pulse ox, all normal with increased BP and HR after Epi administered. She was placed supine with legs elevated above the height of the hear. Pt was anxious so oxygen was administered by nasal cannula at 4 liters per minute. Within the 15 minutes after meds were given, pt had periorbital edema, a "strange " taste in her mouth as well pressure in her chest and the rash did not abate but progressed to her face. EMS came and took pt to ED by ambulance.

5 days after injection in the evening, left side of base of neck felt tender and lump could be felt. Day 6, in the morning, visible swelling could be seen on left side base of neck where it meets the shoulder. Tenderness was still present throughout the day and by the evening around 6pm earache right side started to present itself. 400mg ibuprofen taken at 8:30pm for earache. 1230am 1000mg of Tylenol taken for same earache. Day 7-6:00am , swelling and hardness at sight of injection (left arm), earache gone, lymph node still swollen left side of neck . Felt very lethargic and lightheaded throughout day and some itchiness around injection site. By the early evening of day 7, large red swelling like welts appeared and was itchy around and down injection site. Area was also tender and sore. Benadryl taken at 9pm along with 600mg Ibuprofen. Day 8, redness and swelling still present but no longer itchy. Energy level back to normal. Headache present at 2pm, 1000mg tylenol taken. By 4pm, headache is gone. Some itchiness has returned to left arm, swelling still present.

Started 4 days post vaccine (1/11/21) and lasted 10 -12 days. Tightness in chest and neck. Fullness in chest that radiated up to neck w/ warm feeling. Feeling of faintness. Headache. Rapid heart rate while sitting or standing., bending over. Left eye blind spot; 20 minutes on 1/16/21. Anxiety. Advil, Dayquil did not change any of the symptoms. Some residual anxiety issues regarding tightness and rapid heart rate.

Woke up in early morning with chills, fever, muscle ache, sore left arm. Throughout the day when I wasn't sleeping chills, fever increased to 102.8, noticed headache, nausea, and metallic taste. Into the night and early Jan 24, same symptoms intermittent fever. Jan 25 symptoms more tolerable, but fatigue and arm continues to hurt, firmness, redness, swelling with blotchy, swollen lymph note all noted. Treated at home with Tylenol, Aleve, ice, rest and sleep. Fever ranged from 100.5-102.8

1620: After receiving COVID vaccine, pt c/o tingling on lips and face; hx same s/s w/food allergies inc rash/hives 1624: Benadryl 25 mg po given 1628: BP 168/98 HR 88 RR 24 SpO2 100% 1634: States tingling improved but left cheek feels "numb" 1635: DS 109 1638: States numbness feel improved 1647: BP 162/90 HR 88 1652: Discussed elevated BP; suggested f/u w/PCP. Pt driven home by husband.

After the vaccination I felt like I was drunk and tired which lasted about 2 days. On day 3 I developed a horrible headache and the muscle behind the eye was throbbing and hurting really bad with nausea associated for about 5 days. It made me feel manic and felt as if I was in a psychotic state which lasted from 12/28-1/26 .

I got the vaccine on Tues felt fine later that evening arm was sore couldn't sleep on (right side). I went work on Wed arm felt as if had fever. I informed employee health was told the symptoms was common. I took Ibuprofen before laying down Wed my throat felt as if closing up. Upon me calling my mom voice was screeching . My mom asked my sister to bring me some Benadryl. I contacted the director of employee health was informed to go ER. Then my lips was swelling, Oxygen was fine and I was given Pepcid.I stayed overnight for observation.

Premedicated with Benadryl and then had the following response tingling down left arm, right leg, lips and unusual sensation in abdomen, numbness in right hand and tightening around throat. States that she felt the Benadryl was working and symptoms were less than post 1st dose. today she reports severe arthalgia

Fever, chills, nausea, stomach pain, headache, ice pick headaches, gray spot in right eye vision, joint pain, muscle aches

Reports within 10 minutes of receiving the vaccination felt lymph nodes throbbing under left arm . The pain traveled to the left elbow to the left wrist.. The next day 10:30 am, felt tachycardia, c/o blurred vision with a bad headache. Waited a bit for son to finish his activity and drove self to the Fire Station. HR was 258/minute can't remember diastolic BP but systolic BP 145. Received 2-doses of Adenosine on the way to the hospital. HR down to 145/minute in ER. Received Toradol for headache which was unrelieved. Received EKG, blood work, CT lungs. Resting HR on discharge in the 120's. 1/24/2021 Continued to feel poor with back pain making it difficult to breathe, body aches, headache and pain at the injection site. Was able to return to work on 1/26/2021

Within 30 minutes of the injection I had a lot of nausea and a weird taste in my mouth. This went on for a few hours. Then I had fever, body aches, bone and joint pain, headache, eye pain for about 36 hours. I continued to have a headache with eye pain following this for a day.

I had visual disturbance (shiny vision in left visual field) for about 45 minutes the morning of 1/25/21. I went to primary care and also had an appointment with Medical Center for an eye evaluation. They diagnosed me with an ocular migraine. I have never had an ocular migraine or any form of visual disturbance or migraine previously.

Extreme dizziness, things pulsating with my vision, feeling of blacking out, feeling of blood rushing in and out of my head,

migraine headache. Never had a migraine before. behind right eye severe pain mild nausea tingling right side of nose

@ 40 minutes post-dose, numbness in tongue. @45 minutes, progressed to lips, then lips, then throat. Called 911, Pt bought Benadryl gelcaps, took 50mg. Rescue checked vitals, Benadryl started working so throat swelling started to recede. Pt was observed for 30 minutes post-Benadryl dose. Pt took an additional 25mg dose x 2 that evening. Completely resolved the following morning

LUMP IN THROAT, RED, SPLOTCHY ON NECK, TINGLING OF LIPS AND MOUTH, TROUBLE BREATHING ABOUT 2-3 MINUTES AFTER VACCINE INJECTED. BENADRYL 50MG IM GIVEN.

Patient received her 1st dose of Moderna COVID-19 vaccine on 01/09/2021. Reports arm ache, chills, and fatigue lasted approximately 3 days, but resolved. However, within hours of receiving the vaccine patient also developed a headache (6/10 pain) that is exacerbated by movement. Especially lifting and bending, two actions she must perform frequently. Temporary relief from Tylenol or ibuprofen, but headache always returns. Afebrile, with mildly elevated BP (136/83, which she states is abnormally high for her). Given acetaminophen and asked to return later this afternoon to retest BP, and to check back in after a few days to report if and when the headache ceased to bother her. At the time of this report, staff member has had a headache for 11 straight days, and Q4H Tylenol is not a long-term solution.'

Tongue, roof of mouth and throat felt prickly and sore (same as when you burn your mouth with hot coffee) that started 40 minutes after shot and lasted for 4 days. Exhaustion, chills, and body aches that began around 8pm on night of vaccine and lasted 2 days. Sore arm that began several hours after shot and lasted 2 days.

Patient received 2nd Dose of COVID-Vaccine. Approximately 7-8 minutes later she became light headed, ten minutes after that she her face and neck became very red , hives began to appear on arms, throat very scratchy, voice altered. Patient transferred to the ER where she was treated for Anaphylaxis. Drugs given included IV fluids, Benedryl (PO and IV), Epinepherine, Solumedrol, and Pepcid. Patient was observed for several hours but was discharged the same day.

Symptoms immediately following the vaccine on Wednesday; tachycardia, shortness of breath, dizziness. Symptoms the following day on Thursday; tachycardia, shortness of breath, weakness, fatigue. Symptoms on Friday; tachycardia, shortness of breath, weakness, fatigue, diarrhea, cough, loss of control of extremities, debilitating headache, nausea, dizziness. Symptoms on Saturday; chills, tachycardia, shortness of breath, weakness, fatigue, diarrhea, cough, loss of control of extremities, debilitating headache, nausea, dizziness, blurred vision, sensitivity to lighten and sound, sore throat, stuffy nose, ringing in ears. Symptoms on Sunday to current 2/3/21 tachycardia, shortness of breath, weakness, fatigue, diarrhea, cough, loss of control of extremities, debilitating headache, nausea, dizziness, blurred vision, sensitivity to lighten and sound, sore throat, stuffy nose, ringing in ears.

She was sent to emergency room Feb 2, 2021 by her PCP after calling him with headache, found elevated BP by school nurse, 163/95, vomited x3, left hand numbness but resolved upon arrival, decreased vision brief right visual disturbance. denies fever nasal congestion, sore throat, cough, chest pain. EKG NSR 95, head CT-no acute intracranial abnormality, UA and blood work completed

left side tingly, sorenes on left side, rib cage very sore, when breathing lungs hurted (sore) mild headache, and left eye,cheek,lip swollen and very very sleepy could not open my eyes felt a little spacey.. sore body the third day.

Metallic taste in mouth immediately , 30-60 min later face and hand on left side became numb, next day felt heavy on left side and body aches, by sunday symptoms resolved

On Saturday I felt chills, joint pain, fatigue, light headed. On Saturday checked my temperature, 99F. On Sunday I lost my sense of smell and taste. On Monday, Tuesday and Wednesday I felt so sick, my headache was horrible and I returned to the hospital to get tested. Negative. 7 days later I am still sick and then I decided to go back to get tested again and it was positive. The symptoms lasted about 2 weeks, lost sense of smell and headache. Really bad headache.

pt allergic to shellfish, pt immediately reported tingling of tongue, lips, tingling of hands and feet 50 mg of Benadryl given EMS on site EpiPen given by EMS and transported to Hospital

This morning after breakfast (around 9:00-9:30am) my right eye started feeling strange, but looked fine. The sensation was a sense of pressure or slight numbness. After about 20 minutes, that sensation disappeared and then my right arm started feeling strange, too, as if my joints were swelling and the ulnar nerve was irritated. The right forearm near the ulnar nerve felt slightly numb to touch, as if I were touching Playdoh, or molding putty. All my joints started feeling swollen and heavy, my knees visibly showing swelling. I?ve done some work to alleviate the inflammation, but my right side arm and joints are still feeling heavy and a little warm, with some lingering weird feeling of Playdoh (molding putty) numbness when I touch the area. The numbness is not so noticeable when I?m not touching the area. It seems that it will go away with time and not too serious, but wanted to report in case others experience the same thing. Also, I should mention that the day after getting the vaccine (2/5/21), in the morning when I woke up (7:00am), I experienced an intense one-sided headache behind my right eye that lasted until I gave myself some acupuncture in the late morning. I also experienced extreme arm pain at the site of the injection the day after the vaccine which lasted until yesterday (2/6/21). This morning when I woke up (7am), I felt some local numb feeling (when I touch it, it feels like I?m touching playdoh) at the injection site on the left arm, with minor soreness.

Jaw pain on right side, pain behind the ear. unable to eat. Unable to close mouth/jaw on right side. pain in the right side head and down the neck.

I started having shivering, chills,headache, really bad body ache all of symptoms like Covid except lost of taste/smell lasted for 48 hrs.

Felt fine during the waiting period after receiving the vaccine. As I was walking through the parking lot started feeling very light headed. Went home and rested, took Tyenol but the dizziness never went away. When I laid down in bed it felt like the room was spinning. Woke up today and still feel dizzy and light headed. The only other side affect is a really dry mouth and throat.

2nd dose- from 700pm on 2/1/2021 to 4pm on 2/2/2021- I had severe muscle and bone aches in my hips/ legs/ feet, fever up to 101.4, chills, severe headache and neck pain, eye pain, fatigue. i had on and off again nausea. I did have a sore arm for the next 4 days. I took 400- 800mg Ibuprofen around the clock from 7pm on 2/1/ 2021 to 1230 on 2/21/2021 and switched to 1000mg of tylenol on 2/2/2021 T 9PM. 1st dose- I had sore arm for about 4 days and 4 headaches in one week. I was also tired on and off for the next five days.

Tingling of tongue and roof of mouth immediate. Scratchy throat and cough followed. Had to take inhaler and benadryl.

Patient first had lip tingling 5 minutes after vaccination, but no changes in respiration. Patient began to develop hives 2 hours after vaccination. She came down to pharmacy. She was given 1ml of diphenhydramine 50mg/ml. Measurements of her blood pressure yielded very high readings. Called EMT due to high BP readings.

2/3 AM: Started feeling sick 2/2 and run down and now feels 'horrible' States she has aches all over, has the chills, sore arm and maybe feels like she can't breathe well. She has a history of asthma, and other autoimmune disorders. She is a caregiver for a child with disabilities and attending school. 2/4 8:40 AM: Husband replied that she is 'having a hard time and getting worse. whole body hurts and head and she is coughing bad and having hard time breathing sometimes. she can barely move'. PHN responded immediately that she needs to call her doctor right away and if struggling to breathe to go in to be see immediately'. Asked if she had seen her doctor yesterday and he said

About 30 seconds to one minute after vaccine, throat became very dry. After about 1 minute 30 seconds after vaccine I began to get raised and itchy welts on the left side of my neck. Then I began to get raised welts going down my chest.

Fever 104 an bleeding around left pupil with red vessels of eye. No changes in vision, no nausea, no vomiting, no swelling

Fever of 101 by temple for over 24 hours. Temp at site of injection 102.9. Muscle aches, neck pain, pressure behind eyes, severe fatigue. Oliguria (I was drinking ice water regularly and it took about 12 hours for my urine stream to return to normal)

Minor upper lip swelling around 30 mins after injection. Could have been from wearing mask 2:41 pm. Migraine level headache, followed by chills and nausea. Went away with advil and an hour nap. Around 6 pm. A hive on collarbone and one on neck. Puffy upper lip. Occasional racing heart feeling. Severely itchy ears, inside of mouth, face, and neck. Took Benadryl and symptoms cleared within 30 mins. Random headache, chills, joint pain, and minor itchy skin throughout the weekend.

Dizziness, Hard to Focus eyes, extreme fatigue, severe arm pain (unable to life arm without pain) (began that evening-lasted two full days)

Day after vaccine unrelenting fsevere headache, jaw pain, charlie horses. Day 2 after vaccine arm swelling, HOT, spreading getting larger during the day along with headache. Day 3 after vaccine arm still red, geographic pattern on arm in different location, never localized and very irregular in shape- tingly feeling started in pinky and ring finger of left arm where vaccine was given. Day 4 after vaccine RIGHT had not associated with vaccine has tingly feeling. - like hit funny bone. No numbness, just tingly

Symptoms began 10 minutes after vaccine administration as tingling in the tongue and progressed to swelling of the toungue

gradual onset of mild itching sensation in bilateral ear canals and posterior pharynx along with a tingling tongue sensation after administration of vaccine. No signs of urticaria or respiratory distress (or wheezing). Patient had no other known allergy triggers today, but did have post-nasal drip PTA. Chose to self-administer 0.3mg of epi at 1530 via her own epi-pen which she always carries with her. Post-administration all symptoms resolved, signed a release and left independently

Since the night of my shot, I have had the chills, fever, muscle and bodyaches, I can?t move my left arm where I got the shot, and it hurts to walk. I can?t keep food down and I am incredibly thirsty

Patient called in to report dizziness, aversion to bright light, felt "stoned", slept for 4 hours, chills, fever, vomiting, also reported having bad case of COVID in early November, where she was in bed for 12 straight days.

Two minutes after the vaccination I became extremely hot and my heart began to race. My mouth became very dry and felt like I couldn?t swallow. It passed after a couple of minutes. Red circular rash to the left of the injection site appeared 8 days after vaccination.

I received my second covid vaccine on 1/26. On 1/27 I had severe body aches, headache, burning dry eyes, debilitating fatigue, and could barely move my arm. I had these same symptoms on 1/28

2/6 & 2/7 sore arm, 2/12-2/13 body aches, 2/14-2/15 ping pong sized lump under left armpit & left side lymph nodes in neck swollen, sore jaw on left side. Nausea, headache, congested, runny nose, face/eyes swollen/itchy.

Chest pain, fever (102.7), dizziness, exaggerated body pain, metallic taste in mouth, not able to walk, not able to stay awake for more than a few minutes, swollen lymph nodes under armpits on right arm

Migraine headache, brain fog, confusion, photosensitivity, sound sensitivity. Confusion started within two hours. Fever started within 12 hours. Left side migraine headache with photosensitivity from 12 hours and thru the following 5-6 days.

Patient had an adverse reaction to her first dose of the Moderna Covid-19 vaccination. Patient experienced a metallic taste in her mouth, nausea, headache (slight), slight shaking, and dizziness. She also described a warm, tingly feeling on the side of her neck. She was seated and monitored by pharmacist on duty for at least 30 mins before deciding that she was ok to leave. She decided that she wanted to walk out herself. Her daughter did come to pick her up so she would not have to drive herself. She was instructed to go to the ER if symptoms worsened. I will check back with patient on her condition before end of business today.

1208 Patient received vaccine and was in her 15 min. wait time when she began to taste a metallic taste and flushing skin / hot flashes.EMS was on site and present with the patient. 1208- 147/85,81,20, 97%. rescue drugs were not given. 1217 -147/78,84,18. 97% patient feeling better and symptoms resolved. 1225- 147/85,85,89,18,98%. Again all symptoms have resolved. Patient was released and instructed to call 911 if symptoms come back.

I had a little bit of sore arm, redness not same as Dose 1. The next morning I woke up felt sick around 2pm started exp low grade fever and loss of taste.I missed one day of work.

Had the injection Friday evening. Very quickly had my heart rise and felt shaky (like when you take an inhaler). Heart rate stayed up for about 30 min, shaky for about another 1 and half. but left factily after 15 minutes, as I was shaky, but ok. About 20 min after shot, the tip of my tongue and lips got tingly/numbish. Not swollen, just tingly. (They were very slightly the same way the next day). I went home and contacted hotline. She suggested I call a dr. I called a dr who told me to take a benadryl. I ate some food and took the benadryl. I fell asleep and slept for 14 hours (definitely not normal). That next day (Saturday) I had a headache, upset stomach, lowgrade fever (below 99.9) and pretty good pain in the injection arm. Stomach was settled by that evening, headache was gone Sunday. Off and on low grade fever (highest was 100.3) still ongoing (Tues 3/2, but highest today is 99.1))

Patient states that after first dose of Moderna (27JAN2021 Lot 028L20A) she developed scratchy throat and hives which she had planned for due to history of same. She pre-dosed with benadryl. Today, she pre-dosed with Benadryl 50mg at ~ 1815. She received her vaccination at 1920, at ~1940 she began to have sensation of tongue swelling, coughing, difficulty breathing and hives. VS at time were BP 170/100, HR 92, RR 24 and wheezing. She was coughing when asked to speak or take deep breaths. FF/EMT on scene evaluated and treated with epinephrine 0.3mg IM. After 2-3 minutes patient begins to breath easier and can speak in full sentences. Hives on upper extremities have receded and overall, patient states that she is feeling better. EMS was called and patient was transported to local ER for further evaluation/treatment.

anaphylaxis - throat tightness, hoarseness, coughing, trouble swallowing, nausea, dizziness, pallor, watery eyes, urinary incontinence, sense of impending doom

2/18/2021- Presented to ED after getting her vaccine at Walmart. Immediately she began feeling flushed all over and had urticarial lesions on her face and some trouble breathing, and nausea. She was treated and discharged home. 2/19/2021- Patient was lying in bed, at home, and she started having difficulty swallowing and lip/tongue swelling. She took 50 mg Benadryl and called EMS. EMS gave her Epi and brought her to the ED. Patient was treated and discharged home with instructions to Zyrtec daily for next 3-5 days, as well as Medrol Dosepak. 2/20/2021- Presented to ED with similar symptoms, was treated and discharged home. 2/25/2021- Presented to ED with GI symptoms, was treated and discharged home.

Left arm all the way down to hand excruciating pain Extreme headache 103.5 fever Chills Tiredness Whole body pain Change in taste and smell

Starting on Sunday Feb 28th I was very fatigued. I woke up on Monday after sleeping more than 12 hours with my head feeling tight and hot. My eyelids were burning, the skin around my neck felt irritated and my lymph nodes in my neck were swollen. The burning in my eyelids and neck pain went away by Monday evening. However on Tuesday I woke up with a visible rash on my neck. In the last few days it has stayed even though I have applied cortisone and neosporin on it. It is now warm to the touch and itchy. I also have a rash on my eyelids and my cheek which are hard to see in pictures because of my skin tone. I called my Primary for a virtual consult when I woke up this morning Saturday March 6 because I am feeling itchy all over especially on my back. Additionally, the skin of my elbows and knees (in the joint crease area) are now super warm like my eyelids were before the rash appeared. I also have neck pain again which started yesterday (March 5th) afternoon. It is not a muscular pain. It starts at the base of neck and radiates up to the crown of my head. It has not gone away with either Tylenol or Advil. My chest is also tight--not my lungs but my chest itself.

After the first injection I had mild eye issues which I went to my PCP and they cleared up within a week. The symptoms were dry eyes which was uncomfortable. The second injection dry eye issue has been excruciating and still problematic to where I can?t even open my eyes. I am seeing my PCP and an ophthalmologist to treat this.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Vomiting-Severe, Additional Details: Approximately 5 minutes after administration of moderna vaccine, pt reported feeling hot to observer. RN came out to check pt and pt then rolled eyes to left and back and passed out in chair. RN helped pt to sit upright in chair as was about to fall off chair. After 10 seconds patient able to talk with patient. She stated she still felt tingling in arms but cooling down. Had additional tingling/warm and vomitting episode. Paramedics called. Pt refused transport, parent going to drive to ER.

PT REPORTED TONGUE RIGHT SIDE OF FACE BECOMING NUMB AFTER ABOUT 30 MINUTES OF RECEIVING THE VCACCINE. GAVE PT 2 DIPHENHYDRAMINES (25 MG TABLETS) AND CALLED EMS

On the night of February 25 (day 6/7) I woke up in the middle of the night with my hands itching and right butt cheek. In the morning, there were a couple small hives between my fingers on left hand and a larger one on right butt cheek. I was able to go about my day, periodically itching. That night, I woke up more frequently in the night with both hands itching. Primarily in between my fingers and a few small hives on both ankles. At 11 AM, I noticed a lesion on my tongue. By Friday night I had several more spots and the itching continued to become more bothersome. I took benadryl before bed. I woke up Saturday morning at 1 AM with my tongue swollen and lower right lip swollen as well. These did not itch nor hurt. My hands itched and burned very intensely, I put ice on them for some relief. There were more hives on my hands, ankles, left shin and left knee and right elbow. I went into urgent care at 9 am. Dr prescribed Prednisone and benadryl. Dr. only looked at my hands and mouth. When I got home I noticed I had a large hive bout 2" by 4"above the injection site on my right arm. This did itch, however was not a major concern because my hands hurt quite severely. I took benedryl at noon on Saturday and that did bring the swelling of my lips and tongue down. I could not sleep at all on Saturday night due to the pain and itching. Once the prednisone took effect, I finally got some relief. Monday I went to see the allergist and he also prescribed zrytek twice a day. He suggested I take that for a few weeks to make sure the hives do not return. It is March 9 and some of the hives are still there and bothersome, but the majority have resolved.

Received shot at 7:15 in the evening on March 8th. When I woke up March 9th I had a basic headache. Starting at around 1:30 on that headache worsened to debilitating, migraine like. I couldn?t get out of bad, I felt nauseated on and off. I couldn?t look at electronics and had a little bit of light sensitivity. I slept as much as I could. The headache lasted all evening. When I woke up today, March 10th, the headache was almost gone and no nausea.

The left side of my neck, ear and head hurt along the same path. It hurts to to tears to turn my neck, lay down and make certain movements. I took Advil and it eased the pain. However, I can still feel it.

About 1 hour I started getting muscle aches and headache, today severe nausea muscle and headache, temp of 102.4, sometimes I cant see straight, I get hot and sweaty between being cold.

TINGING IN THE LEFT (STARTED DAY OF, BUT TOOK THIS AS A SIDE EFFECT ON WEDNESDAY BC TINGLING DIDN'T GO AWAY). BODY DOESN'T FEEL NORMAL STILL. WOKE UP ON 3/12/2021 WITH A POPPED BLOOD VESSEL IN RIGHT EYE

Recieved vaccine on 03/11/2021 @ 4:40pm. Experienced Flu like symptoms (body aches, chills, muscle soreness, headache,) also injection site swelling and pain the day after vaccine for entire day (03/12/2021). Flu like symptoms subsided by the following morning (03/13/2021). Woke up the 2nd morning after vaccine (03/13/2021) with a swollen bottom lip on the left side only(no pain or itching, but had a tingling sensation), a red rash on my neck (no pain or itching) and continued injection site soreness, but much reduced from previous day.

Patient started having swollen lips this morning and they are also numb feeling - patient has contacted md

On Sat 3/ 6 I woke of with bright red eye lids. My face burns when water touched it. Then my eyelid skin peeled over the next few days. I had a very pale eczema patch on my neck prior to the vaccine. On Saturday night my husband said my neck was the reddist he'd ever seen it in 17 years. I said it was burning, and then looked in the mirror and realized it was as red as my eyelids had been in the morning. Like a severe sunburn. I had been parched all day like I had a lump in my throat. I took benedryl for the next 24 hours. My breathing remained fine and it passed .

Body aches, chills, fever up to 103, jaw pain, migraine, exhaustion Full body rash/ hives beginning 4 days post injection

10:00 am on the 5th, I woke up and felt not very good. Tired and achy. I had a fever that developed that day. I rested most of the day. Two days after that (about the 7th or so), I noticed that I had a rash on my right arm - elbow height (not injection site) - upper forearm. Not the bulls eye rash but just a rash and it itched super bad. I called the on-staff doctor because it was after hours. He said I could use cortisone cream on it to help with the itching. I also took some ibuprofen because I had the fever. The cream helped get rid of the rash within a couple of days. I still had the overall skin itchiness on my legs and stuff that I still had from the first vaccine - that overall itchiness had never gone away and I still had it. February 25, I woke up and I had some mild hives on my face and my eyelids were puffy and swollen and itchy (face was kind of itchy). I kept using the anti-itch lotion (from the first dose) and I quit taking my supplements to see if that would help. By the 26th, it was pretty bad. She prescribed me some steriods - methylprednisolone. She said if the hives left don't start it yet because she didn't want me to start it that night. So next morning, it wasn't horrible, so I didn't start taking them until March 1st and they are six day ones. It got pretty red and hived out and rashy for a few days and the steriods seems to clear that by the six days. So by the 7th it was almost gone and by the 8th was all gone. It feels like the other itchiness is gone, too. The lymph node under my left arm, I thought had gone away but now a couple of weeks ago it felt like it came back and it still is feeling a little swollen.

Moderna COVID-19 Vaccine EUA..... Symptoms began at 5am on the morning of 3/17, swelling of the tongue and lymph nodes, also sweeling on left side of face by the ear and jaw. Headache, elevated heart rate, weakness

Rash left arm, nerve pain left side of the body, left eye twitching, headache (temple area), severe chills repeated for 6hrs, fever 12 hrs 102

Became ill with Covid a month after receiving the second dose. Had many symptoms including: fever, chills, stuffy nose, body aches, nausea, diarrhea, sore throat, fatigue, loss of taste and smell.

Passed Out; Possible Seizure; Swollen Tongue; itchines; Headache; shivering; shaking really bad; A spontaneous report was received from a nurse who was a 42- year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced shivering, shaking really bad, had a headache day afterwards, tongue was swollen, passed out and doesn't know if she had a seizure and itchiness. The patient's medical history was not reported by the reporter. Concomitant medications were not provided. On 19-Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection. On 20-Jan-2021, 24 hours after vaccine administration, the patient reported that she was shivering and shaking really bad and had a headache day afterwards. On an unknown date, she reported that her tongue was swollen. She also reported that the she passed out and doesn't know if she had a seizure (date unknown). The patient reported that she took ibroprophen for her headache and diphenhydramine for itchiness. On 28-Jan-2021, she reported that she felt fine. Treatment for events included ibroprophen and diphenhydramine. Action taken with mRNA-1273 in response to the events was unknown. The outcomes of events, experienced some side effects was unknown, shivering, shaking really bad, had a headache day afterwards, tongue was swollen, passed out and doesn't know if she had a seizure and itchiness, were considered recovered/resolved on an unknown date.; Reporter's Comments: Based on the information provided and a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Headache and chills are consistent with the known safety profile of the vaccine

Jan 14: Shot #1 of Moderna at 7 am at Hospital o Very sore at injection site for 2-3 days o Retrospectively, I recognize a subtle shift in my mood after the first shot that has persisted. I felt inexplicably sad in the afternoons and continued until March 1st anxiety event. I also found myself crying more. o Sleep ? I woke up a handful of times with heart racing and then would fall back asleep. This is never had happened before February 11: Shot #2 of Moderna at 7 am at Hospital o Within 11 hours of the vaccine had fever, chills, aching and 103 fever. Next day my period started a week early. o Over the course of the next two weeks my anxiety levels heightened; o March 1st acute event that mimicked an anxiety attack (no previous history of anxiety or attacks); followed by my first night of many nights with no sleep. o Insomnia ? worsened each night. o Internal thermostat dysregulation ? I would get very cold and shake uncontrollably and then feel hot after the shaking episode; shaking would often happen in the afternoon and especially after meals. o High Blood pressure o Night sweats. o Muscle weakness; tingliness running through arms and legs. o My heart would skip a beat (several times a day). o My entire body would feel like it was pulsating uncontrollably but I wouldn?t be visibly shaking. o Muscle stiffness. o Pain in lower right back region (ultrasound yielded nothing). o Extreme exhaustion. o Loss of appetite and dietary changes (no longer can eat rich foods; only bland small meals multiple times a day) o Weight loss (5-6 pounds) in one week (146-140) o Unable to focus; blurry vision. o Unable to partake in intense physical activity; can only walk. o Unable to participate in household work because of low energy. o Unable to participate in job duties due to inability to focus on screen for long periods of time. o. Second week, March 8th, muscles in upper back burn and intense pins and needles in my shoulders arms to finger tips. T This sensation woke me up from sleep on Friday March 12th. o Unable to focus; blurry vision. o Strange headaches- behind eyes, in temples, on one side of the head. (don?t? have a history of headaches)

THIS WAS MY FIRST DOSE OF THE MODERNA VACCINE: 5 minutes after I had the vaccine, I started feeling off. I felt completely out of it, I went pale, shaking. The EMT's were with me and checked my pressure. It was through the roof. I'm otherwise a healthy person with BP regularly of 120/80. My BP at 3:20 PM -- 148/96 3:35 pm - took one 25 mg of Benadryl. 3.45 - BP 139/92 3.52 - BP 122/88 3.55 - Took a SECOND benadryl pill 25 mg. (throat felt heavy when swallowing) 4.20 - BP 120/82 EMT stated that it was an ALLERGIC REACTION cause VASO VAGAL SYMPTOMS. My throat felt swollen (I have NEVER experienced this before). I was sitting in the car for almost 2 hours before I felt somewhat comfortable to go home. My husband drove me home.

Shortly after administration of Moderna Vaccine, pt. developed lip swelling and circumoral erythema, pt was given Benadryl 50 mg po which resulted in swelling and erythema resolving shortly after.

I have Moderna arm (starting about 8am on 3/22/2021), and a pinprick sensation on right forearm starting evening of 3/22/2021. It progressed to itchiness in V1 distribution of right-sided scalp. As of 3/24/2021 there is pruritis of V1 distribution of right scalp down to the eye. There is some mild redness to right eye and skin surrounding eye and forehead. Mild enough that I cannot decide if it is from rubbing and scratching it versus being present at baseline. It is helped by a concoction similar to Icy Hot (not applied near eye). I have had chickenpox as a child. There are no vesicles (so far). I am not immuno-compromised. If anything (given my allergy history) I have too robust of an immune response to everything I will definitely follow back up if this develops into shingles. I would be very shocked if it were shingles. I am wondering if the vaccine did not get my immune system so primed that it's attacking anything remotely foreign (varicella zoster dormant in my trigeminal nerve perhaps?) such that I would have itching and burning pain associated with shingles but no actual outbreak of shingles (let's hope there's no outbreak coming later...). Another tidbit of information that suggests robust immune response is that I took my regular allergy shots on Monday, 22 Mar 2021 and the spots (2 shots) whealed up higher than usual. Those went down by morning of 23 Mar 2021 but the Moderna arm has stayed and the V1 burning/itching sensation continues. I am a psychiatrist, so I know my symptoms are not currently worrisome enough to seek medical care. I will if symptoms worsen.

1st dose, 12:10 pm pt c/o feeling flushed, rapid pulse, cold legs and body, funny taste in mouth, light headed, and nauseous. BP 140/80 HT 84 O2Sat 99% , Repeat VS 140/80 HR 72 O2sat 98%. Pt reports history of allergy to Augmentin, with hives. Denies anaphylaxis. 12:15 PM pt reported feeling a little better. Pt declined EMS evaluated that was offered. Pt signed Chesprocott refusal form and was given ED precautions. Pt was advised to contact her PCP this afternoon. Pt?s husband who was present the entire time will drive the pt home.

Within one hour of injection - numb lips, tongue; swollen throat; labored breathing; heavy arm; headache, nausea, dizzyness

Swollen lips, red rash at the edge of the lips, itchy, burning sensation for 12 days now. Using Chapsticks for 12 days now and Abreva for 2 days now.

PATIENT STATED HER TONGUE AND THROAT FELT TINGLY AND ITCHY. PATIENT DECLINE THE OFFER FOR DIPHENHYDRAMINE INJECTION AND EPIPEN. SHE STATED THAT SHE SUFFERS WITH ALLERGIC REACTION ALL THE TIME AND BENADRYL USUALLY WORKS. GAVE PATIENT 50MG OF DIPHENHYDRAMINE ORAL SYRUP. WAITED 15 MINS TO SEE IF PATIENT FELT BETTER. SHE SAID TONGUE FELT BETTER BUT NOT THROAT. THAT'S WHEN ANOTHER PHARMACIST ON DUTY ADMINISTER THE EPINEPHRINE 0.3MG INJECTION INTO PATIENT'S THIGH. PATIENT STATED SHE FELT BETTER RIGHT AWAY. 911 WAS CALLED AND AFTER PATIENT WAS EXAMINED BY PARAMEDICS, SHE DECLINED TRANSPORTATION TO HOSPITAL. PATIENT WAS COUNSELED THAT EPINEPHRINE WILL WEAR OFF AND SEEK EMERGENCY HELP IF SHE CANNOT BREATHE.

A lemon size swelling has appeared on my forehead. It is changing brown in color- resembles ringworm with swelling but no ring showing , metallic taste continues

Mild swelling of tongue and throat. Very mild difficulty breathing. Waited and monitored. Symptoms started to lessen approximately 2 hours after received vaccine.

Really really dizzy; Weakness; Blurry eyes; Severe headache; Fever; Muscle pain; Bad nausea; not able to work; A spontaneous report , was received from a consumer (patient), concerning a 42 year old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe headache (headache), fever (pyrexia), dizziness (dizziness), weakness (asthenia), blurry eyes (vision blurred), muscle pain (myalgia), inability to work, and bad nausea (nausea). The patient's medical history was not provided. No concomitant medications were reported for the patient. On 5 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 030A21A), intramuscularly for prophylaxis of COVID-19 infection. On 05 Mar 2021, two hours after the vaccination, the patient experienced severe headache, fever, dizziness, weakness, blurry eyes, muscle pain, inability to work, and bad nausea. On an unspecified date, headache and fever went away. The events muscle pain, dizzy, eyes blurry, and little weak were not recovered/not resolved/ongoing. The patient was not able to work, got dizzy when she tried to get on the computer. Treatment details included taking aspirin for headache. Action taken with second dose of mRNA-1273 in response to the events was not reported. The outcome of events, severe headache and fever was considered recovered. Dizziness, weakness, blurry eyes, and muscle pain were considered not recovered. The event of nausea was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

OS 42 Y.o. Female AAox4, anaphylactic reaction. translator was used. Pt complained of extreme difficulty breathing, swollen tongue, difficulty swallowing. Pt was out side of vehicle pacing back and forth in distress. Prior to epi admin pt. Was having near syncope also. Pt. Appeared pale in color and distressed, pacing back and forth with anxious look on her face. Pt pulse rate also was approx 110 prior to administration, and strong. RR was approximately 20. Bp 186/92 post administration. Tx. Pt was examined and verbal interview conducted through interpreter. EMS summonsed. Pt advised tongue was starting to swell significantly, and increase in SOB, nausea and. Near syncope. Pt administered 0.3 mg epinephrine through autoinjector to r thigh @ 1128. Pt advised after approx 6 min post injection that tongue swelling was decreasing and she was able to breath again and was not having near syncopal episodes. Pt care transfers to hospital with a non-emergent transfer to hospital.

Arm pain right after first dose, could not do much the first two days, Tylenol did not help at all. First dose triggered severe menstrual cramps two days later. Pain was an 8/9 on a scale of 1-10. Like labor pains. Trouble standing, walking, sitting comfortably. Full dose of Tylenol did not help. Heavy bleeding. Tongue and throat mild numbness at the height of pain. Extremely painful to pass stool and urinate. Worst pain lasted two days. 8 days later mild cramps persist, passing stool still uncomfortable. Day 7 cramps got worse for half a day. bleeding/spotting lasted 7 days (usually 3). Night 7 arm started to hurt again and itch, hives formed injection spot. Next morning (now) arm feels hot, itchy, sore and irritated. Still cramping in lower abdomen today.

Menstrual period stopped, fever, chills, nightmares, injection pain, severe headache, ear pain, tiredness

COVID Vaccine received on 12/30/2020 at 2:00pm on her left deltoid. On 12/31/2020 she reports severe fatigue8/10) with LUE burning and numbness from injection site to her 4th and 5th digit on her Left hand. She took Tylenol at 0500 am with minimal relief noted. She also reports around 9:00 pm her right eye began to swell and she took 25 mg of Benadryl with some improvement noted.

Pt with urticaria, swelling to face and itching to mouth that occurred within 10 minutes of administration. She was treated with benadryl 50 mg IM upon onset of symptoms. She did not have any stridor, hypoxia, or tachycardia or hypotension. She did have a change in pulse from 70s to 100 then back to 70s 10 minutes after administration of benadryl and stated she has a paradoxical reaction to benadryl. She experienced pallor and livedo after administration of benadryl which resolved after 15 minutes. She experienced urticaria on 01/01/21 into 01/02/21 requiring continued antihistamines which did subsequently improve.

Started the following day December 29th about 9PM having diarrhea. Diarrhea continued on December 30th. Also on December 30th my left eye began to swell. I took benadryl that evening before going to bed, but woke up the next morning December 31st with both eyes swollen. The left eye being worse and now under the eye was red and extremely itchy. Contacted employee health at hospital on December 30th and 31st. where vaccine was given and left a message detailing my side effects. Contacted my own primary dr on December 31st and was seen by Dr who believes I have had an allergic reaction to Moderna vaccine. I was prescribed predinsone and zyrtec for 5 days.

I felt weak, my heart rate went up to 120's, my SBP went up to 150's, I had SOB and felt I was thirsty and I need air and I had severe headache few minutes about 5 -20 minutes after I had shots. I took Ibuprofen for severe headache and sore on my Left upper arm at the injection site. Yesterday 1/2/21 I observed at the injection site has some redness in circular area, warmth to the touch and slightly sore. I met my PCP last 1/28/20 and had my physical exam.

Dizzy, lightheaded, extreme tingling in arms and hands, tingling in the face, numb tongue, heart palpitations, feeling faint, blurred vision, shaking

Known allergic reactions-requesting vaccine. Had personal EpiPen with her. Itchy throat, watering eyes.

states that she has severe itching on left arm, radiating to back. Taken to private observation area with EMT staff. Has hives on left side of back and left arm. Very itchy. 1055 BP 138/98; HR 98; 96% sats on r/a; RR 20. 1058 gave benadryl 50 mg by mouth. Gave ice pack for itching. Place on left side of back with raised red papule. States relieves itching. Continued to observe. 11:02 BP - 124/88; P- 90 strong and regular; 99% sats on r/a. Swelling decreasing, no signs of severe allergic reaction. Papules decreasing in redness. 11:15 Left side itching, redness and papules diminished. Now has them present on right arm and right upper back. P-89; sats 98% on r/a RR-16. 11:18 c/o swelling under left side of tongue with red raised papules on face and head. EMT called ambulance. 1122 unit arrived. 1140 Patient declined transport. Husband with patient. Husband states he is transporting patient per personal vehicle to hospital.

Dry throat progressed to cough that continued to severe cough, difficulty breathing, while driving. Pulled over and contacted paramedics. Outcome unknown at time of report

Approximately 2 minutes following the injection client complained of "tingling" in mouth and lips. No visible "rash/hive" or swelling present. Able to swallow without difficulty. Vital signs within normal limits except for b/p noted as 150/110. States b/p has been elevated prior to this time. Oxygen saturations remained at 99%. Noted as being "hot" no flushing observed. Chewable Benadryl 50 mg administered and EMS contacted. Patient stated during this time that she had previously taken inhalers (both albuterol and steroid) prior to the clinic and admitted to having chronic breathing problems. Referred to Emergency Department. Refused ambulance and was taken to ED by private car.

Patient received Moderna vaccine 1/6/21 at 12:00 pm. At approximately 5:00 pm, patient stated her left arm was hurting, tender and hot to the touch. at 11:00 pm, patient began chilling with body aches. Pt felt dehydrated and very thirsty. No fever. On 1/7/21, patient still had body aches and slept most of the day. Pt took Tylenol throughout day. On 1/8/21, chills and body aches improving, but patient had no appetite and arm still very sore and uncomfortable. On 1/9/21, patient feeling much better. Body aches and chills gone, only symptom now is arm still tender at injection site.

Client began having tightness in neck and face, tingling around mouth, and blotchy skin. Spoke with her primary, he suggested administering epi: 0.5 ml of 1mg:1000mL. Administered dose in R deltoid 30 minutes following vaccine administration, client began feeling better immediately.

30 minutes after receiving vaccine bilateral numbness/tingling to hands 60 minutes after "chemical taste" in mouth with dryness lasting entire day; 6-8 hours after headache; fatigue x 1-2 days; arm pain swelling x 2days

Patient reported headaches , strange taste on her mouth, and tingling on the left arm 2 minutes after getting the vaccine. As per staff: Patient was A/O, Denies SOB, Palpitation, Throat itchiness or closing. Her vitals signs were: BP:120/74, HR:92 and Regular RR:20, Lung clear. Apple juice given. Patient stated feeling better around 0355 and discharge home with instruction to call heath care provider if symptoms persist

Pt stated feeling light headed, difficulty breathing, dry mouth possible related to anxiety. Symptoms lasted about 8 min.

Felt a burning sensation in my hands right after getting the shot. Went home, took 2 Aleve and iced my arm for 5 minutes at a time on and off about 4 times. Hours later, about 8 pm I was laying down on the couch on my left side for at least 20 minutes. When I was getting up my upper left arm was very numb and I had a strange sensation on my left side like my blood had pooled over there but it was very numb in the area. I never have felt anything like that. The sensation did go away over the course of a few minutes. Soon after I was having shooting pain in my hands. It felt like arthritis pain. This did not last too long but came back here and there. My lower back started hurting a little bit out of nowhere. And then when I went to bed I started having random body aches all over. Like brief shooting pain in different parts of my body. I did have some dryness, weird sensation in my throat at times. The body aches kept me up until 2 or 3 am. It was resolved by the time I woke. I never felt that I had a temperature. And I was not sick prior so I felt it was a cause and effect from the vaccine. I took 2 Aleve and I went to work. Temperature checked at work and I was 97.1, normal. Wore a mask all day, social distanced at work and I had mentioned to my manager upon arrival that I had symptoms/reaction? after my shot. I did still have some residual, arthritis type pain in my hands during the day and more so when I got home. I also felt fatigued when I got home from work but I was half awake most of the night before due to the body aches. Felt pretty good, normal on the second day after the vaccine.

Approximately 30 minutes after the injection clients voice became raspy. She reported 1-2 seconds of blurred vision, that resolved. No breathing difficulty or wheezing, no dizziness. B/P 128/88 Pulse 59. No other complaints from client. No swelling or redness at injection site. Waited X 60 minutes, no changes. Instructed client to closely monitor and seek emergency care if needed.

Felt achy, heavy, very thirsty, restless (couldn?t get comfortable) The next day felt extremely tired (the whole day). Did not feel ?normal? until 2:00am on day 2 going into day 3.

Neck hurting, tongue swelling and numbness, ear and face swelling and hot to touch. Benadryl,2 epi pen shots,steroids

within 10' of injection , developed Wheezing, flushing and lip/ facial swelling. Transferred to ED and treated with epinephrine, Benadryl and albuterol. Po Benadryl and Pepcid. Sx resolved and remined in ED for 6 hrs observation. D/c'd to home

04:30PM PT STATES "LIPS ARE TINGLING, HEAD ITCHES". DENIES SHORTNESS OF BREATH, TROUBLE BREATHING, SWELLING OF LIPS/TONGUE, OR DIFFICULTY SWALLOWING. ALERT, ORIENTED, PINK, W/D, RESP REGULAR WITH EASE. NO RASH OR HIVES NOTED. 05:00PM ALL SYMPTOMS HAVE RESOLVED.

Called to see pt in drive up lane 7 min post vaccination. She immediately felt after the vaccination, numbness and tingling in L face on the buccal side and her L arm. She felt like her L side of the face and eyelids were swelling. She was agitated and worried. Past medical history of breast cancer and axillary swelling. Initial examination lungs CTA, regular tachycardia. Pt moved to observation area. Initial vitals: BP: 154/82, HR 129, 97% O2 Benadryl 25 mg po given at 10:25am EMS notified and first injection 3mg Epi pen injection given at 10:41am; 911 called. BP 154/82, 136, RR 20, O2 sat 99% 10:43am. Second epinephrine 3mg injection given at 10:44am. BP 162/84, HR 131, RR 22, O2 sat 100% at 10:49am. At 10:49am, she suddenly was short of breath, general mailais, delayed ear swelling, and was put on a stretcher and 10L non rebreather. She was brought to Medical Ctr at 10:54.

1530:This RN to car pt reports hives to chest and swelling to mouth.Urticaria noted to anterior chest.Pt's husband states her cheeks appear swollen.HR100,BP 100/70. EMS called immediately.Pt removed from car 1537 and transported to medical tent, laid flat.Upon arrival to tent pt states "I feel like my throat is closing." Pt did bring her own epi pens. This RN verified epi pen dosage 0.3mg and administered to left thigh 1539.EMS arrived 1542, report given to paramedic.Pt reports feeling better after epi pen administration, hives are improving to neck. EMS team transported pt to back of ambulance and to Hospital. Pt's husband updated.

Tight chest, shortness of breath, welts, red rash, swollen tongue, swollen bottom lip, itchy body, itchy mouth and throat, fatigue, tingling on legs, arms and hands

I had a swelling and my arm got hot at injection site ( small allergic reaction- a red line). It felt like when I used to get allergy shots for cats. It got better by that Wednesday (01/13/2021). I had taken a Benadryl that date for my itchy nose and dry eyes (I thought it was seasonal allergies.) Today one week and a day after injection my arm swelled up again and is hot . A large red bump appears at the injection site. Again it feels like when I used to get my allergy shots. My throat feels itchy as well, breathing is normal.

Approximately 15 minutes after injection I became itchy; the itchiness covered my body from the top of my head to just above my knees. About 5 minutes after that my face became tingly and my breathing became shallow. At this time my blood pressure, pulse ox and pulse were taken. They were all normal, however my breathing was still labored. I used my rescue inhaler, was given a double dose of allergy medicine and 800mg of ibuprofen. Within a couple of minutes my breathing had returned to normal. Approximately 20 hours after injection I suffered from a headache that lasted around 6 hours. I also became very tired; the day of the injection I slept 10 hours and the following day I slept 12 hours. On both occasions I woke up to an alarm, so I have no idea how long I would have slept on my own accord. Final thing to note which may not be related, but merely a coincidence: since receiving the vaccine, I have been unusually thirsty.

After first dose, patient was instructed to take 50 mg of diphenhydramine 30 minutes prior to her dose of vaccine and also take 2 puffs of albuterol immediately before the vaccine. The patient did as instructed, but approximately 15 minutes after the vaccine dose the patient experienced bronchospasm and coughing, and states her tongue was itching. She received 0.5 mg epinephrine and was transported to the ED for observation and treatment. The patient received a 10 mg dose of dexamethasone at 1916.

24 hours after vaccination I had tingling and numbness on right side of face, heavy eyelids, "pulling sensation" in neck. Unable to lay flat. Tingling and numbness would switch from right side to entire face but mostly on right side. Headaches and noticed increased heart rate two days after vaccine. One week after vaccine numbness and weakness extended down right arm and leg, able to move leg just felt "weak". I thought I was having a stroke or TIA. Made an appt. with the NP and she did full neuro exam and everything came back normal. Also, made an appt. with my PCP. Still continued to have headaches and weakness improved. Did get a COVID test since was still having headaches and it so long since vaccine, received test 1/12/2021 and it was negative. This past weekend was the 1st time I felt "pre vaccine" 17 days post vaccination. I am truly hesitant to take my 2nd dose scheduled on 1/26/2021.

Immediately after injection metallic taste in mouth by 1 hour after returning home marked urticaria LUE and induration and extended rash L rib cage and flank. Rash persisted 10+ days; pt took photos and reported to V-Safe. Presented for second vaccination - deemed ineligible b/o immediate allergic reaction per CDC criteria.

Dizziness, lightheaded, unable to focus visually, fatiuge, swelling and itching at the vaccination site 2 weeks post vaccine

Severe pain in left arm, heard a snapping sound at time of injection, very strong metallic taste in month, approximately 37 minutes after injection itching was noticed around neck and back of head, approximately 45 minutes after injection entire body was covered head to toe with hot and red hives, very large hives under arms and on sides of body, quarter sized hives on vaginal area and bottom, small, pin prick hives all over back, legs and arms, very itchy head

at 15 mins post injection started to get extremely hot from Right side to left. Then like half of my body was cut head to toe in half and the left side of my body went numb and tingly. I could barely move my extremeties. Tounge began to burn like a 9volt battery was being held on it. I was taken to the ER and was told I had a rash on my chest neck and chin. I was treated with Epi IM, Benedryl, famotdine, then had epi again because my tounge felt fat and like a 9volt battery again. Epi went IV second does and had extreme pain with that. Had IV tylenol . Along with IV fluids. For the next 5 days I have had pain in my right harm , shoulder , neck into my head to the tip of my nose. The first 4 days were so bad that I could barely move and would get nauseated and throw up if I moved just right. each day the pains in my right arm,shoulder, neck and head did get better by about 25 percent each day. You could feel it getting better with each day I woke up. I was also having ear pain that seemed to be worse on 1/19/21. A PA checked my ears and said they were clear.Today, 1/22/21 is the first day I have been able to turn my head without being so sore and feeling nauseated. I was also very fatigued until today, 1/22/21. My hips and lower body are sore today and upper body seems to be less sore by 75%. I still am numb at times in my feet and fingers but can turn my head a lot better today.

Immediately felt sore in arm then felt hot and sweaty in post vaccine waiting room dizzy blurred and blacked out vision... Vasovagal syncope episode Emt and nurses came right over gave me oxygen and water.....felt better after approximately 25 minutes of treatment....drank 3 bottles of water was able to walk and leave without going to hospital around 12:15pm Arm severely sore for 48 hours.

After receiving the vaccine on 1/19/21. I noticed I lost my sense of smell on 1/21/21. I was sent to take the COVID-19 test on 1/21/21 in which I tested positive.

Headache, fatigue, muscle pain, chills, joint pain, eyes irritation. The symptoms started yesterday night and I still have the symptoms.

Jan 7th: Headache, body aches, extreme fatigue. Jan 8th: Lips swelled, hives on face, bilateral lower legs. Started daily Loratadine, pepcid, and benadryl. Jan 9th: Lips split at corners from swelling. Hives spread throughout body, including peri area. Continued OTC meds and cold compresses on affected areas. Jan 10th: Hives continue to spread to both ears. Continued OTC and Started Desoximetasone 0.05% cream to ears only once a day. Jan 13th: Telehealth appt with PCP. Started Methylprednisolone 4mg Dospak: completed Jan 18th. Helpful. Jan 19th: Skin reactions began with intensity again.

eye swelling and tearing, increased pulse rate, nausea, abdominal cramping, runny and stuffy nose; redness, pain, itching at injection site; foggy headedness and lethargy. Symptoms started the day of injection 1/21/21 and have continued to this day 1/24/21

Severe jaw and ear pain on left side of face. Diagnosed with neuropathy and possibly early Bell?s palsy from vaccination. The pain started early Friday morning around 2 am and has persisted

Itchy throat and watery eyes. Benadryl administered with initial resolution of symptoms. Later, patient experienced swelling of eyes, cheeks and mouth. Advised to take Benadryl q6h.

At 08:15, first response was called to tend to a hospital employee at the vaccine clinic as she was unable to swallow and disclosed that she self-medicated using Benadryl 2 hours after her first COVID vaccine d/t symptoms of "scratchy throat" She did not say "yes" to any of the consent questions prior to administration of 2nd vaccine dose to indicate any concerns. Symptoms progressed to difficulty breathing within a few min. and 25 mg of Benadryl IM and Epi 1mg SQ was given on-site. The employee was subsequently transferred to ED at 08:40 am. She was given Decadron 10 mg IV and Famotidine discharged home. Today 1/26, her wheezing/stridor persist and she has schedule to f/u w/ her PCP.

Initial ringing of bilateral ears s/p injection lasting 3 hours. Next day tempt 100.1-101 with fatigue, malaise, chills and headache. Starting 1/22 episodes of flushing, chest tightness, dull head pain and dizziness. Episodes come and go. Will often have numbness in bilateral arms during and after dizziness. No LOC at this time.

22 minutes after vaccine had severe racing palpitations, a heart rate of over 150 and visual changes. Lasted one hour. Visual changes and some feelings of chest pressure lasted the rest of the day.

22 minutes after vaccine experienced severe racing palpitations, elevated heart rate over 150 bpm and visual changes. This lasted one hour. Had mild chest pressure and the visual changes the rest of the day.

day 2 sore arm tingling fingers restless sleep. day 3 sore arm tingling fingers cotton mouth. day 4 tingling fingers cotton mouth. day 5 soreness under the arm hard to put arm all the way down to my side cotton mouth tingling fingers. day 6 tingling fingers soreness worse under the arm radiating up over the shoulder

Severe redness of face, throat, and chest, "felt like my body was on fire"; hives on bilateral inner arms and entire chest; burning sensation on soles of both feet; facial and lip swelling. Oral benadryl was taken and symptoms subsided after 45 minutes.

Several minutes after receiving Moderna COVID-19 vaccine, patient's face started to become flushed, swollen, and she had trouble breathing. This anaphylaxis reaction started at 3:40 PM . First dose of epi was given at 3:43 PM. After first dose of epi was given, patient's breathing normalized and swelling was reduced. EMS was called during this time period. At 3:49 PM, patients lips and mouth started to swell and patient couldn't breathe. At 3:50 PM, a second epi pen was given and patient could breathe easier. EMS arrived shortly after and was taken to emergency room.

Patient given Covid vaccine at 0906, patient remained at clinic post injection to observe for signs of allergic reaction. At 0920, patient c/o lip tingling & itching to chest & hands. Provider assessed patient and Benadryl 50 mg IM given at 0925. VS obtained temp 98.9, HR 73, RR 20, BP 154/106, O2 sat 99% RA. patient reports she has not taken her BP meds yet this morning. Patient took BP meds at 0950 in presence of provider. Patient speaking in clear, complete sentences without respiratory distress. Airway patient, skin is warm & dry, mild erythema to upper chest noted where patient was scratching/no rash present. VS rechecked at 1020 temp 97.6, HR 65, RR 20, BP 140/97, O2 sat 98% RA. Patient reports she is feeling better & does not feel bad or itch as intensely as she did initially. 1025 Patient discharged home with instructions to notify PCP if symptoms worsen or go to nearest ER. Patient verbalized understanding.

Awakened with eye pain, severe light sensitivity, tearing. On 1/21/2021 I went to visit the optometrist and was immediatley referred to the opthamologist for a same day appointment. I was told it looked like a herpetic keratis (HSV 1 virus) by both physicians. I have a left corneal transplant. I have never had an HSV virus affect my eye in the past. The last fever blister I had was > 5 years ago. Treated with maxitrol qid, Acyclovir five times a day, Cyclogel bid. Severe light sensitivity resolved after about 24 hours. On f/u appointment on 1/26/2021 he said that the herpatic lesion was looking better. Eye pain resolved. I am continuing medication.

1/26/2021 0230 pain at the injection site, body aches, increased heart rate, fever, and extreme tactile, auditory, and visual sensitivity. Symptoms resolved 1/27/2021 at 0500.

Loss of taste, scratchy throat, skin burning, and rash approximately 4.5 hours following vaccine administration. Approximately 5 hours following vaccine administration patient appeared out of breath and disclosed that her throat felt as if it was getting tight. Patient was directed to call 911 and presented to the ER.

She received her first dose of Moderna COVID-19 vaccine at 7:30 AM on 1-22-21. At 9:15 AM, she felt lightheaded, her heart was racing, and vertigo. She had a nurse check her blood pressure and it was 101/65 and her heart rate was 138 bpm. She felt presyncopal so she went to the ED for evaluation. By the time she got to the ED, she felt her throat was scratchy, and when she would lie down flat she felt her throat was occluding. She notes that she is s/p tonsillectomy in 12-2020, and considered whether that was playing a role in her symptoms, but she had not had any of those throat symptoms for 1 week prior to getting her COVID-19 vaccine. In the ED, she was given IV medications and IV fluids. ENT was consulted. Her symptoms got better with medications, she is still experiencing some throat dryness but otherwise is feeling back to her usual self. She never had any rash, flushing, itching. She had a little tenderness at the injection site only. She never had any difficulty breathing, lip/eye/tongue swelling, wheezing, coughing, shortness of breath, vomiting/diarrhea/abdominal pain. She did have nausea when she felt vertigo.

Took vaccine on 1/21/21. Symptoms on 1/23/21 included widespread rash, lips swelling, hives, dizziness, trouble breathing. Received epinephrine, steroids, benadryl. Diagnosed with acute anaphylaxis due to possible allergy to Polyethylene Glycol

Within 5 minutes after shot my lips were feeling tingly. at 15 minutes out a co-worker sat by me and I told her about my lips and she commented that I had a large red mark/rash on my neck. I went to the nurse and she asked if I was nervous - which I was. She told me that I should take a Benadryl. I took a single Benadryl. I went home and was still feeling the tingling sensation and had the rash which had spread onto my chest. I took another Benadryl about one hour after the initial shot. This reduced the rash and tingling sensation. as it wore off about 4.5 hours later the rash, tingling lips and facial swelling started to appear. I took two more Benadryl and called the on call doctor at my physicians office. He advised me to continue taking Benadryl until 48 hours after the vaccine, I did this every 4-5 hours including waking during the night to keep up on it. I was also taking Advil at this point to try to help with the swelling and a dull headache that had set in. I should note that I have never had any facial injections or anything like unto it. For 40 hours post vaccine I did this. After 48 hours the symptoms seemed to go away. I did start feeling a metallic taste in my mouth that night and the following night so I took a single Benadryl at bedtime those nights and that seemed to resolve it. I have had a slight cough and congestion on days 3-6 when I woke up in the morning, but that would resolve itself within an hour of being up. The doctor on call that I spoke with the first night did advise me to still get the second dose, but to take some Benadryl ahead of time and to make sure that the clinic has a current EpiPen on site.

Anaphylaxis. 2 minutes after injection I developed tingling of lips and tongue. 5 minutes after I couldn't speak well and developed a cough. 10 minutes after ER doc gave me pepcid 20mg and zyrtec 10mg. Cough and shortness of breath started and tongue swelling. I was then taken back to an area with team including ER doc and 2 nurses. Given benadryl liquid and ultimately epi injection. Called Ambulance and taken to Hospital where I was given more benadryl IVP, ativan, and monitoried for 8 hours. Pruritic, congestion, and difficulty talking since day of shot. this is day 2 after injection

A few minutes after receiving the vaccine I began to feel light headed, dizzy and my heart rate was climbing. I wear an Apple Watch and notice my heart rate was steadily climbing. I asked the exit secretaries to be seen by a nurse and as they were getting a nurse my heart rate reached 169 and I was feeling faint and beginning to shake. When the nurse came she noticed how white my hands were and my breathing was becoming labored. The nurse called a code white and an ICU nurse and respiratory specialist arrived to assess me. I thought I would pass out and they had me lay on my back with legs up. They tested my blood sugar and were assessing my vitals. My breathing was fast but I was still able to breathe. My heart rate started to slow down but remained somewhat high. they helped me into a wheelchair and escorted me to the emergency department. I was assessed for cardiac concerns and labs were taken. After a couple of hours in the ED the dizziness started to subside but I had excessive thirst and dry mouth and slightly swollen tongue. I had feeling of butterflies in my stomach off an on. My heart rate stabilized and I was cleared to go home after four hours.

After about 5 mins after the shot, I started feeling "foggy" with my vision and mental clarity. After about 20 minutes, I grabbed my water bottle and both arms felt weak when I lifted them and they felt like they were floating. I had a sudden urge to cry when this happened that lasted for 30 seconds. I was not anxious or nervous to take the vaccine but my body may have overreacted to the sensation of my arms but it didn't feel like a panic attack that I had a few in my earlier 20s after the birth of my child and undiagnosed thyroid disorder.

Extreme dry mouth the day following the injection and small blisters on my tongue the following two days. I?ve never had that before.

Felt quesy about 15 minutes after shot. 45 minutes after shot got really tired, eyes started hurting/getting irritated, itchy throat. 1hr - 2 hrs after shot sever stomach cramping, and chills Next morning - still had slight chills, left arm sore, and still extremely tired.

Elevated temperature of 105 started early am hours of 1/20/21, during the night, and did not decrease to 102 until 6pm. Also had loud ringing in ears. I?m still having ringing in ears.

During the 15 minute observation following the 1st Moderna vaccine dose, the patient reported her tongue 'felt thick,' flushed skin, redness on face, neck, hands, BP=98/60, HR=100. Patient felt 'jittery' and 'heart racing.' Was transferred to ED for evaluation given that patient reported her tongue 'getting tighter.' In the ED, the patient was treated with diphenhydramine 25mg x 2 doses, methylprednisolone 125mg x 1 dose, famotidine 20mg x 1 dose, and NS IV fluids. Hypoglycemia was ruled out with CBG=87. The physician avoided treatment with epinephrine due to it being listed on her allergy list with a reaction of 'shortness of breath.' Symptoms resolved over the next 3 hours. The patient was discharged home with a new prescription of oral prednisone taper. Subsequent follow-up with her primary care provider, in consultation with an ID provider, recommended that this patient NOT get a 2nd dose. Covid-19 vaccine was added to her allergy list with a reaction of 'anaphylaxis.'

Fever (101 degree temp), body aches, splitting headache, nausea- onset 10 hours after vaccine x14 hours. Of most concern is the development of periorbital edema, erythmatous, pruritic eyes bilaterally, onset 24 hours after receiving vaccine- with slow, progressive development over the course of 2 days until medical treatment was sought.

Developing an unusual sense of smell of metal mixed with formaldehyde and vinegar since yesterday. Smell is intermittent and lasts for about 5-10 seconds.

Same day of vaccine later on that day my face & lips felt like a tingling sensation & on my cheeks it felt very itchy. Closer to 5pm same day my eyes felt like burning sensation like they where dry. Then my whole body felt very itchy. By 6pm I started getting the chills, body aches, & slivering. It all lasted only one day. I got my smell back for 1 day & now I could smell but it has to be very close to my nose. I also feel like I don't have the same energy I feel like my energy level is not the same.

On the same day of the vaccine later on around 9pm I got a headache, then about 10 min later my throat felt itchy & dry. then after 10 min after I had body aches, I kept shaking & felt nauseous. Around 10pm I had a fever of 102.4 it continued for about 3am I fell asleep for about 2 hrs. Then I started feeling nauseous again but I never threw up. My arm was hurting a lot where I got the vaccine it was very itchy & it was very hot the itchiness started coming to my face as well this lasted all day long on 12/29/2021. Then on 12/30/2020 the fever stopped the chills where still there. Also on July 2nd I caught covid & since then I was not able to smell since then. After I got the vaccine I was able to smell but it only lasted for about 5 days. The vaccine made a knot the swollenness in my arm & itchiness lasted for about 2 weeks to go away.

Patient with generalized body flushing advancing to numbness and tingling to right side of mouth, lips and cheek. Diffuse flushing over body. Vaccine given at 8:15a - and symptoms began 10 minutes post injection. Patient requested 911. HR120. Able to speak and breath without difficulty. Benadryl administered IM x 1. No throat tightness.

The sides of my tongue are swollen and bumpy and my neck is stiff amd I have a headache . I have pictures of my tongue.

Pt received dose #1 of the Moderna vaccine today. Within minutes of sitting in observation the pt c/o experiencing burning in her ears and feeling "weird." EMS called and pt evaluated by paramedic. Pt then c/o tingling in throat. Pt transported to ED.

Fever of 106, extreme swelling of arm at injection site, tinnitis, shortness of breath, tachycardia, headache.

Moderna COVID-19 Vaccine EUA: Around 4pm, began having normal side effects of fatigue, headache. That night at 12:30am, woke up with temp (99.9) and had chills. Was shaking so badly from them, i was having uncontrollable hand tremors and couldn't use my finger to type on my phone. Was awake for the rest of the night. In the morning had a 101 , also had loss of appetite, extreme fatigue, nausea, headache, weakness. But the adverse event I'm reporting is blurred vision. I think it began around 12pm on Wed, so almost 24 hours the shot. It was primarily my left eye. There was also a great deal of pressure from behind the eye. It was difficult to read. After about 2-3 hours it passed. It returned briefly again in the evening, although more mild. Today (2/4/21) when I woke up, my vision is fine and the pressure behind the eye is gone.

Chills, fever, weakness, headache, blurry vision, loose bowel movement, rash, enlarged lymph nodes (confirmed by mammogram and ultrasound ), dizziness ; welt

fever- 101.7, chills, headache, nausea, body aches- (more so joints- hands, ankles, knees and entire back), injection site with redness, swelling and extremely sore with difficulty moving upwards and outwards from body. nasal congestion and ear pain on left side ( same side as injection). s/s started about 140 am on 2-4-2020 (day after injection). s/s lasted all day on 2-4-2020, woke up on 2-5-2020 with arm soreness, redness and edema, but improved. all other s./s besides lower back pain resolved. temp-99.4

Sore right arm after injection. Jaw pain right side, unable to open mouth or eat for over 24 hours. Right arm 2 weeks later still has a red rash like area and warm to the touch and painful.

I got after the first dose what some people are to experience after their second dose. This could be because I had Covid in November and probably have circulating antibodies already. My right arm had 10/10 pain starting around midnight waking me up and was persistent with any movement which extended up into my neck and down to my elbow area. Ibuprofen and tylenol did not help with the pain. Currently on post-vaccine day 3 I still am unable to get full ROM to my right arm due to pain but it is better than yesterday. Other symptoms I had was the fevers, chills, headache, extreme hypersensitivity to my skin, and bone pain with movement especially to my hips and back with walking which seems to be subsiding. whole body aches/pain which seems to be subsiding as well. What I don't see mentioned in a lot of the expected side effects is TINNITUS. I am experiencing moderate tinnitus. I have experienced this previously in my 20's when taking a full dose of aspirin and I avoid aspirin products because of that. I did not see anywhere that there is aspirin products in these injections. It has not subsided yet at this time and I am wanting to report this. Not sure if others are experiencing this as well.

Headache - ibuprofen - hasn't dissipated as of today Arm soreness - ibuprofen - better by 2/1 Blurry vision (right worse than left) - no treatment - better by 2/2

The first shot I received on December 28th. I have fatigue and a headache for about three days and my arm did hurt for close to 2 1/2 weeks, the second week it was red, 3 inches in diameter, raised, also it itched very badly for 4-5 days. I received the second maderna vaccine on 1/28/21 about 5:45 pm. I had noted about 8 pm mild burning to the lower part of my legs and bottom of my feet that evening. Later I started to have mild nausea about 9 pm, but it resolved, and I went to bed. I woke up about 3:11 with diarrhea and my body and mainly "my skin" started to hurt, as if someone was taking a wire brush to my legs, and slowly pulling out each hair, but at one time. After another hour or so, I started to have severe chills with increased nausea and more severe severe body/bone/joint pains. I took Tylenol at this time. I noted that the bottom of my ribs or rib cage hurt with breathing, also I had upper abdominal pain, severe lower back pain and a headache. The next morning I stayed in bed all day and took a few baths, I had multiple episodes of diarrhea. I was nauseated, but no vomiting. I still had chills, bodily shaking, fatigue, muscle and joint pain. I tried to sleep off and on through the day. That evening I did have a temperature of 101.4 with using Tylenol and Motrin. It did come down later that evening, but I still had severe pain of my body and my skin hurt, even the hair on my head, during the night about 2:45 am I took a bath and that did help with my body. on Saturday evening I was able to start getting up and moving around, but a severe decreased appetite. I've noted a drastic change in taste since having the vaccine and have lost 9 lbs in the past week. I am able to taste, but everything has a different taste. I have had two covid tests PCR's in order to return to work. I also have had the continued bilateral leg burning from the calves to the bottom of my feet. The sensation is if you are cold outside and come back in and run your hands or feet under warm water to warm them up and that pain you feel when they warm up is how they feel, but on a milder level than that pain. I also have had post nasal drip that has started in past 5 days and while at work in the ER on Tuesday I had a PA look at my ears and I had a large amount of fluid behind both ears. I had a zpack that I had at the pharmacy that I had refilled and have taken that for the past four days with some relief. I still feel fluid in my ears, but mildly better. The headache and fatigue is getting better each day. My appetite is still very diminished as well as how things taste in my mouth, it is way different than anything I have ever experienced before. I also had an Issue on Monday 2/1/21 when I was working, I felt in my brain, as if it was just not as sharp, cloudy. I had an issue with typing on my right hand for a few hours (upper row on rt side) that has since resolved, but it was a truly "off" day. It has taken me this entire week to start to feel even a bit more back to human. So what remains- the bilateral leg to bottom of feet weird burning sensation, decreased appetite, taste alterations, post nasal congestion with bilateral fluid in ears, shortness of breath with activity, mild burning in lungs with activity (working out/running in the cold weather). this was just a side note that was copied to the bottom. I was unable to touch my arm right arm due to swelling and pain for about three day, which I know is to be expected and actually wasn't as sore as long as the first shot. I did take a few doses of Motrin 800mg but tried to stay with Tylenol and Zofran, and hydrate. I noted that warm baths helped the most and the use of a heating pad on my lower back and an ice pack on and off my head for the headaches. Thank you

I received the second vaccine on 1/27/2021, at 255pm. Around 730pm that night I started to feel very lethargic. My normal temperature is usually around 95-97 degrees. When I woke up at 430am, my temperature was 99, the lethargy was much worse, I had the chills. I called into work, and then went back to bed until around 10am, when I woke, and was drinking coffee, i suddenly started having visual hallucinations (only had this once with a on old antidepressant as a teenager). I took my temp and it was 100degrees. By 130pm, my temperature was 103 degrees, with severe chills, lethargy. I slept 20 hours total that day. I eventually took 1000mg of Tylenol sometime the evening of 1/28/2021. I was very ill the entire night, but welt 98 % better on 1/29/2021. Following the first vaccine, on 12/29/2021 at 605pm, I was very tired for 7 days. The 5th day after the vaccine, i had coughing, chest heaviness, sinus congestion fairly significantly. I felt like I was on the verge of becoming ill. The Tuesday following the vaccine, I got a COVID19 test out of concern, but it was negative. Eight days after the vaccine, I had a sudden severe migraine at 930 am the caused immediate double vision and extreme pain.

Vaccinated 2/4/21. On 2/5/21 in the AM, she developed a dull headache, sore throat and injection site pain/swelling. She felt that the pain went into the lymph nodes and into her back. The headache, pain and sore throat worsened over the afternoon. By the time she got home at 4:30pm she had whole body aches and was feeling really bad. She developed facial and eyelid swelling. She applied ice. Her eyelids swelled so much that they cracked. Her face has a dry, red rash. She later got up to take bedtime medications and she passed out. She began vomiting. She declined an offer to call the ambulance or to go be seen by a doctor. She took tylenol for pain and zofran for vomiting. On 2/6/21, she developed diarrhea. She was

My tough went numb and swallow to where it was hard to talk for about 4 hours. The top of my tough still burns a week after.

02:30 reported feeling flushed and hot--B/P 160/80 P-120 feeling tingling in mouth, tongue felt thick, no SOB, no tightness in chest-- Dr in to see and orders per protocol 0.3mg Epi given at 2:40pm 2:50pm reported feeing better P now 84 no resp issues, tong feeling better, still with tingling in mouth 3:20pm sent to ER for observation--B/P 145/70 P-102 report from ER---symptoms did return later and she received Benadryl/steroids/another epi and no further symptoms after that discharged from ER approx 10pm

5 days after the injection I had swelling and redness at the injection site. Red ring 3 inches around site and edema. I also had lymphedema on the left side. From my neck to my ear on the side of the injection. The lymph at my clavicle was the size of a golf ball for several days. I was exhausted and took Motrin for the pain in arm, ear and neck.

I had a strong immune response to the second dose (fatigue, fever and body aches) for over 48hrs. Within 72 hrs of the second vaccine, I developed tinnitus in both ears.

In the morning of 2/11/21 received very bad headache, then once at work, shakes, trembling all over my body, sever pain behind right eye, upset stomach, cold/hot spells, heavy weight on my chest (breathing light and fast), dizzyness. 2/12/21 - upset stomach, headache, fatigue

couldn't move her face and all the left side of her body/ Drooping Face/ Bell's Palsy; couldn't move her face and all the left side of her body; palm went numb; hip pain; lower leg pain; heart racing; really low blood pressure; arm was itching, her whole body was itching; Tongue and roof of the mouth numb; really bad headache; rash on both arms; nausea; vomiting; freezing; chills; Severe allergic reaction/Allergic symptoms; diarrhea; low grade fever; A spontaneous report was received from a healthcare professional who is a 43-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and couldn't move her face and all the left side of her body, her palm went numb, headache, body aches, chills, had a low-grade fever, diarrhea, arm pain, arm itched, whole body itching, rash on both arms, nausea, really bad headache, vomiting, freezing, low blood pressure, hip pain and lower leg pain and a bad headache. The patient's medical history included helicobacter pylori, two cervical spinal fusions, allergies to shellfish, strawberry leaves and dust. No concomitant product use was reported. On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20-A) in the left arm intramuscularly for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 013L20A) in the right arm intramuscularly for prophylaxis of COVID-19 infection. On 26 Dec 2020, approximately 20 minutes after receiving the Moderna COVID-19 vaccine, the patient reported she experienced a headache, body aches, chills, had a low-grade fever, diarrhea and arm pain. The headache and arm pain resolved after 4 days. On 23 Jan 2021, after the patient received her second dose of the Moderna COVID-19 vaccine, she reported her arm itched, then had whole body itched, a rash on both arms, was nauseated with a bad headache and vomiting. She stated she went to the emergency care unit and was given diphenhydramine 50 milligrams intramuscularly, a steroid injection and intravenous fluids. She stated, her legs and arms were shaking, she was freezing, and her teeth were chattering. Everything disappeared 2 hours later. The patient stated she went home but continued to vomit, had fevers, headaches, chills and body aches for two more days. On 30 Jan 2021, the patient reported she had a rash, was nauseated and her heart was racing. She road in an ambulance to the emergency room. She stated her palm went numb, she could not mover her face or the left side of her body. She stated, "they thought I was having a stroke". She also reported her blood pressure was low. The patient reported, they gave her Tissue Plasminogen Activator (TPA) and diphenhydramine. She reported she was able to mover her arm a little better. On unknown date, the patient reported that she was in the Coronary Care Unit (CCU) on bed rest with monitors. The patient reported she had hip pain and lower leg pain that was making her limp and a bad headache. On unknown date, the patient reported she had a magnetic resonance imaging (MRI) and computed tomography scan (CT) and stated, "it only showed a narrow spine". The patient stated she had a spinal fusion (date not provided). Treatment for the event included diphenhydramine, a steroid injection, intravenous fluids, and Tissue Plasminogen Activator (TPA). Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, headache and arm pain, were considered resolved on 30 Dec 2020. The outcome of the events, arm itched, whole body itching, freezing, rash on both arms, were considered resolved on 23 Jan 2021. The outcome of the events, couldn't move her face and all the left side of her body, her palm went numb, headache, body aches, chills, had a low-grade fever, diarrhea, rash, nausea, really bad headache, vomiting, low blood pressure, hip pain and lower leg pain, were considered unknown.; Reporter's Comments: This case concerns a 43-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and couldn't move her face and all the left side of her body, her palm went numb, headache, body aches, chills, had a low-grade fever, diarrhea, arm pain, arm itched, whole body itching, rash on both arms, nausea, really bad headache, vomiting, freezing, low blood pressure, hip pain and lower leg pain and a bad headache.Very limited information regarding these events has been provided at this time. Further information has been requested.

Started feeling mild throat tightness around 5 minutes after vaccination, then 10-15 minutes after vaccination lips felt numb. Client was able to swallow and there was no swelling. Client was monitored for worsening symptoms which did not present, and client refused transport to ER. Client's partner agreed to transport to nearby urgent care for further evaluation, outcome unknown.

Very strong post vaccine reaction, severe malaise continuing into third day, HA, sl. Nausea and stomach pain. But worst is inability to lift left arm, severe left arm pain, even joint pain in left wrist. Could barely lift L arm on day 2 after (Sunday) and again unable to lift it day 3 after (Monday). First dose, I had arm pain, trouble lifting it 1 day, pain for a week and mild soreness for the whole month. Pre-existing joint pains from autoimmune were worse for a week, but this second dose - it only seems to be vaccine side, including left jaw, left eye pain, left collarbone pain near a previously affected injury.

Upper respiratory symptoms developed about 18 hours after vaccine dose, including sneezing, runny nose, itchy face and eyes, as well as itching at injection site.. Fatigue onset at that time as well. Treated with Benadryl, neti pot, Flonase, warm compress and rest. Symptoms alleviated after 2 days. Injection site is still slightly red and irritated 8 days after vaccine.

Starting February 18 - today (Feb 23) soreness under left arm --most painful 19-21 Feb 20-22 -developed large 3-4 inch pink circle over injection site, itchy at some times but not often -under left eye became red/pinkish then became slightly swollen, almost similar to a stye. Both are clearing and are almost gone but not 100% took benadryl and tylenol 1-3 times a day throughout feb 20-22

Chills, fever, severe headache started 13 hours after vaccine. Mild tinnitus started 36 hours after vaccine then continued getting worse. On day 13 after vaccine now and still have tinnitus and occasional pain/pressure in ears.

For first shot, it was hot right away = I could feel it go down my arm as hot, like fire. As soon as I stood up my scrubs were wet with sweat. They said that I was getting red and flushed. All within a minute. They said my eyelids were starting to swell - upper and lower eye. They had me leave with an ambulance to go to ER. In the ambulance, they started an IV and they gave me Benadryl through IV and they took my blood pressure - it was elevated. I started feeling better. I could breathe. It took 10 minutes to get hospital. The swelling in my face went down. At ER I felt fine. I asked the paramedics ambulance to drive me home but they said that I would just discharged after we arrived. They gave me Pepsid and something else - antihistamine at ER. I had gotten off medication for the immunologist visit which was already scheduled prior to vaccine - but after the vaccine she just got me on higher doses of the medications. February 11th, second dose of vaccine was taken.

Big red blotch on site of injection, about 3.5 inches in diameter, a little itchy and a feeling of dry/numbness on tongue.

The area of my arm where the shot was administered became hot, swollen and red. This happened within 8 hours of shot. When I woke up the next morning, the site was raised and swollen more than the night before. It had the appearance of cellulitis. It was still hot to the touch. I marked the edges of the rash and it progressively got bigger over the course of 48 hours. I still have a mark on my arm where the rash was. I also had severe jaw and neck pain. I felt like my wisdom teeth were pulled with no lidocaine. I has boughts of nausea and was very tired. I tried to put ice on the area of my arm that was swollen, but it did not help.

43 yo female received second dose of Moderna COVID-19 vaccine on 1/27 @1239. Approximately 10 minutes after administration, patient began experiencing lip tingling and sensation of itchiness in throat. Patient given cetirizine and famotidine without relief. Patient continued to report lip and tongue tingling/burning, dry cough, and sense of anxiety. Upon examination by physician, no tongue swelling, stridor, or wheezing observed. Mild erythema noted on chest, not neck. Diphenhydramine 25mg oral solution was administered and close monitoring continued including serial tongue examination and throat/lung auscultation. BP 138/82, HR 84. Approximately 5 minutes after the dose of diphenhydramine, noted a new sense of altered speech and shortness of breath. Tongue noted to be mildly edematous, increased as compared to prior exams, with clear view of oropharynx, still with no stridor or wheezes. Epinephrine pen 0.3 mg was administered to left thigh. EMS was called at this time as well, and 2L supplemental oxygen was administered. Noted improvement in symptoms after the epinephrine and tongue appearance returned to normal within about two minutes, speech normal. Continued to report feeling anxious. BP 143/80, HR 116 after epinephrine. EMS arrived and handoff given. Dexamethasone 8 mg, diphenhydramine 25 mg and lorazepam 0.5 mg given in the ED. Patient eventually asymptomatic after 4 hours and discharged with EpiPen prescription @2051 that same day. Patient reported having urticarial and rash after her first vaccine. She has never had an anaphylactic reaction before, but did develop mucosal blisters with Bactrim and ciprofloxacin.

I developed fever of 101.7, had rigors, sweats, bone and muscle ache. I experienced a zapping sensation in my head that traveled down to my jaw. It felt like an electric shock that lasted a few seconds .It went from top of my head to my left jaw and ear. If felt the pain in my back molars. This happened at least 15 times. In a 24 hour period. It was not a headache.

On my way back to home I looked at the clock it is 10:38AM when I saw my face really flushed in the mirror and started feeling that I could not feel tongue, inside the mouth was also numb and tingling, my gums and tongue and cheeks and lips. Got home and went to bed around 11AM and woke up at 2PM feeling worse the numbness now was going down my throat, like it was swelling. Took 25 mg of Benadryl and called my PCP who advise to go to the ER. At the ER they did a CBC and a CMC or a CMB not sure. They also gave me 15mg of IV Benadryl and 8 mg of IV Decadron. About 15 min after receiving the IV meds at the ER I started feeling relief. Around 8PM I was released to go home. No symptoms next day.

Extreme fatigue, chills, sensory nerve cold shooting sensation in upper chest, back, upper arms; tingling in face, numbness around mouth/lips; low grade fever, dizziness/nausea: Given prednisone and antibiotics for prior infection that presented 4 days after vaccination with continous, worsening cough (bronchitis), albuterol; following onset of extreme fatigue, change in appetite, chills, etc..., 4 days of worst symptoms, just beginning to improve slightly 2/26/21; given anti-nausea meds, IV fluids in ER, several days of continuous rest and sleep, and prayer; not fully recovered yet

As a prophylactic measure after my reaction to the 1st dose. I took 50mg of IM Benadryl prior to receiving the vaccine. . My vaccine appointment was for 9:40AM. I waited 30min at the vaccine site and felt ok so I went home. Got home around 10:30 and laid down. Felt drowsy because of the Benadryl. I woke up around noon feeling my lips "buzzing" and my tongue numb. Called my PCP who sent a RX for another IM Benadryl 50mg. I was able to take it around 3:30PM and that made the feeling on my tongue and lips go away. Around 9PM I started feeling chills, general malaise. And it went on through the night. Next day I felt really fatigued and slept most of the day. I went to work that night and it was a struggle. Took a Tylenol during my shift and next day once again slept throughout the day. At night I was feeling much better.

Felt like a panic attack. Short of breath, heart racing, tunnel vision, dizzy tingling face/lip. Worst of it lasted about 2-3 hours. Very fatigued afterward.

Slight nausea and about 2:00 am -woke up with an excruciating headache - worse when I was lying down. Sensitivity to lights. Fatigue throughout the day as well. I called clinic at 8:00 am (where I work, too) - spoke with a nurse through triage. They told me to rest and that I should stay on schedule for my second dose (didn't think it was from vaccine). Told me I could take 600 mg Ibuprofen about noon that day and finally started getting relief from headache. I did take another Ibuprofen when I went to bed. On the 13th,I was back to 100%. I don't usually get migraines - it was really weird because I felt worse when I was lying down.

Sharp pain in both ears that come and go; fever; rash on stomach; hives on legs; severe body aches; chills.

Weird Taste in my mouth within 2 minutes and Accelerated heart rate. From the time of injection until current, chills, intermittent low grade fever, headache and body aches different from my normal aches. Worse GI issues, memory issues worse than normal, feeling of disorientation at times, little difficulty catching my breath (only used rescue inhaler once). I felt a bit better about a week and a half post injection. But, then, started to feel worse, including vaccinated arm feeling heavy and sore again - February 27, 2021 - noticed reddish/ pink abnormal circle around injection site this is new, delayed, overall worse malaise, I felt a general feeling of yuck. I know it?s not a great descriptor, but, it kind of fits. Basically, lupusy, but worse.

I experienced muscle weakness in lower extremities, chills, headaches, facial weakness, vision disturbances (blurry vision), diagnosed with guillain-barre syndrome.

Nausea, Vomiting, Headache, Left arm pain, unable to lift arm, lymph node swelling under left arm, All over joint pain, All over muscle pain, Double vision, Left side abdominal pain, Left sided lower rib pain, Pain option inhalation, Jaw pain, Ear pain, Throat pain, Neck pain, Left breast pain, Facial pain

10 minutes after shot sharp pain for about 10 minutes then it went away. Light itching also went away at same time. About an hour and a half after, stinging and burning eyes that has not gone away. started 11:30am and it is now 5pm at time of report. Been advised to call eye doctor tomorrow. Burning not so much it tears up but a constant burning feeling in both eyes.

10 am on 02/25 moderna vaccine was administered and patient waited the 15 minutes without incident. She later called the the clinic at approx. 1300 and was complaining of feeling like her throat was swollen and she was having tingling in her throat. She denied any shortness of breath or difficulty breathing. Instructed patient to go to the ER immediately or call 911. Patient states that she will go to the ER. Spoke with the patient on 2/26 and she states that she did go to the ER and waited for 2 hours and symptoms started to resolve and she left the ER without being seen. Patient states that she did not take any medication for the symptoms. She was feeling fine on this day.

12pm Post vaccination reports tingling to lips w/slight swelling, and itchiness to neck, no rash noted; medical monitoring x 30 min, po hydration offered / consumed; BP150/98 P91 denies any additional complaints 12:30pm Reports symptoms resolve, BP 130/90 P88; released from facility w/selft

2am woke up with severe chills and a severe migraine. At 10am severe migraine progressed to skin on scalp feeling like it was pulled too tight. From there I began to feel an internal tremor in my head, almost like if you ran a jack hammer all day and then stopped, that shaky, off-kilter feeling. I used the bathroom that morning and had massive diarrhea, experience a vaso/syncope episode and passed out. All week I felt like this and experienced nausea, dizziness, heart palpitations, severe migraine, internal tremor, severe anxiety and severe thirst. By Friday, 2/26/21, it got so bad and my blood pressure dropped to 112/50, that I was taken via ambulance to the ER. They gave me IV fluids, ran labs, EKG, etc. Blood pressure went up to 137/91. Released to rehab at home. 2nd ER visit to Hospital on Sunday where they repeated labs, EKG, gave me fluids and treated symptoms. Both trips I was labeled Tachy.

5-15 minutes after injection: Tasting metallic Difficulty swallowing Throat tightness Chest tightness Coughing Red chest 27 hours later: Flushed and warm to touch face and chest

I started to notice intermittent tingling and numbness that would travel from feet to legs to arms, sometimes to lips. It was not constant, some days it was worse that others. No pain, or swelling noted with this. Unaffected by position or movement. Also had very painful sciatica down R leg (something I have had in the past but that was resolved) this lasted for about two weeks and the numbness and tingling has lasted thus far for a month.

Moderna Covid-19 Vaccine EUA Severe Tinnitus, started day after vaccine, been 3 days and it?s getting worse

About 15 minutes after the shot my tongue was swelling and my throat. I was taken to the ER where they gave me an IV of Prednisone, Benadryl and after 2 hours I was discharged home. I have not received the second dose of the vaccine .

On day 8 I got Covid Arm at the injection site. Lasted for 3 days. On 3/721 6:30am I woke up for work and had terrible chest pain. It knocked me back a few steps. Examined my chest and only experienced the pain when I moved a certain way. Thought I had pulled a muscle. Went to work feeling exhausted and my eyes burned. Came home early from work and passed out. Noticed that when I lay down my hands swell. Next morning I work up fine. No pulled muscle. No pain. Never experienced anything like it. I started my monthly cycle that morning. It is over a week early.

The arm that had the injection was sore. Limited range of motion and sensitive to the touch. Lasted 36 hours Developed, headache, tiredness in the eyes (stinging), and a fever of 99.8F on 27Feb2021; took Tylenol/Ibuprofen. No symptoms on 28Feb2021.

22 minutes after the shot 1:04PM tongue started to feel tingly and numb, followed by the lips. Felt flushed. 1:07 PM I started to feel a tingling in my throat. Took a benadryl given to me by EMS. 1;18PM Started to feel lightheaded. Had trouble speaking (slurring words) 2:30PM Felt like I had been drinking (I don't drink). Noticeable by my peers and my husband. Acting loopy. Altered taste of food. Everything tasted like blood. Issues with my tongue/lips subsided after about 4 hours. Taste Issues resolved by the next morning. Light soreness on the left arm on the day of the shot, better the next day. One week later, 3/24/21, Vaccine area felt warm, hard, swollen to the touch. Arm felt like someone had hit me with a bat. Pain went from Vaccine area to fingers. Finger joints felt swollen. Lasted for about a week Armpit felt swollen, bumpy (grape sized bumps), and painful. Lasted for more than 1 week.

pt stated that after she got the vax she started feeling really bad. She can hardly mover her left arm. Her arm is swollen and had a red mark around the injection. She has fever, headache and is fatigued. Next day she has all the same symptoms plus chills and has a funny taste in mouth. She is alternately ibuprofen and Tylenol for her head ache and fever (temp 101.5) but neither has helped. Pt states she will go to the ER if she doesnt feel better within the next 3 hours.

Dry mouth. Soreness & pain in arm of injection, shoulder & neck stiffness & muscle pain, tiredness. From 30 minutes after injection & continuous throughout the day & night. While these are not severe, because of the lack of time given for proper research, I felt reporting any side effects (even minor ones) were important for your research & statistics.

Day 1: woke up to my heart racing, lethargy later in the day along with startling to sounds, seeing things not there in periphery, felt sunburned in armpits, bend of legs & front of shins, rash in armpit that came & went, hot spots on skin in various areas, felt I was burning up from the inside out, waves of nausea. Day 12: random itching on throat, chest & arms(started slight on day 10 increased til day 12 then went away), felt sunburned all over, rash on chest that went away in approx 10 min, shoulder & wrist aches

Within 10 min. of having the shot, the right side of my face started to go numb. I first noticed my right ear and then it moved toward the center of my face, and even the right edge of my tongue (from back to tip). Over the following days, I did notice that my right arm felt more numb as well. Now after 1.5 weeks after vaccination, the right side of my face continues to be number than the left. I have some non-length dependent small fiber neuropathy anyway, but my left has always been more affected than my right. After my shot, I saw a dramatic exacerbation of numbness on my right side.

Patient received Moderna Covid 19 vaccine lot# 031A21A expiration 08/28/2021 0.5ml to right deltoid at 09:45 a.m. on 03/10/2021. Patient verbalized No known drug allergies. Patient was asked to wait in parking lot area for monitoring of adverse reaction. At approximately 09:49 a.m monitoring officer called to RN that patient needed assistance. RN, LPN, EMT-P, LPN and , LPN went to assess patient at her vehicle. Patient reports "she feels like her throat is tingling, itching, and closing up and just weird." Patient also reported that "she could feel her throat swelling." RN assessed for any rash or swelling and patient only with chest redness but no rash. RN assessed vitals. BP 138/90, HR 92, Respirations 14. Patient educated on epi injection and possible side effects and patient verbalized understanding. EMS contacted to come assess. At 09:51 a.m. Epinephrine Injection (Auto Injector) 0.3mg given to right thigh w/o difficulty. Lot# 0FM534, Exp 09/2022. Patient monitored. Patient stated at 09:55 "I can already feel my throat getting better and it doesn't seem to be swelling anymore." EMS arrived at approximately 09:57 to assess patient. Vitals taken by EMT at 10a.m. BP 184/129, HR 88, O2 sat 100%, Respirations 16. EKG performed by EMT . Results were normal. EMT assessed patients throat and patient continues to report "the swelling and tingling is getting better and I do not feel short of breath." EMT recommended ER visit since epi was administered for eval. Patient declined and states "she feels better and knows what to do if reaction starts again." EMT recommended patient to take Benadryl when she gets home and to go to ER with any additional problems. RN checked vitals again at 1012 a.m. BP 172/120, HR 80, Respirations 16. and asked patient to continue to wait for 20 more minutes for additional monitoring. Vitals at 1031 a.m BP 168/110, HR 78, Respirations 16. Patient continues to report "she is feeling much better and ready to go home. Patient left at 10:33 a.m.. Spouse driving. RN contacted patient same day at home at 1353. Patient stated she took 50mg of Benadryl at home and is resting and feeling much better and questioned if she could still get her second dose of moderna vaccine. RN educated she should talk with her Primary Care physician regarding any additional vaccines. Patient verbalized understanding.

I am emailing you about filing a petition for the Moderna COVID-19 vaccination that I received on Wednesday February 17, 2021, at the Department. I went to my primary care providers for my annual physical and to address my concerns with the vaccination. I gave blood work. Later into my afternoon, I notice that I began to itch across my sternum and I thought it was an allergic reaction to some of my common allergies. I took some Benadryl to calm the itching to get rest. I was out of work from Wednesday February 17, 2021, @ 1300 to Friday February 19, 2021, without pay, returning on Monday February 22, 2021. On Monday February 22, 2021, I came into work and felt fatigue, light headed, headache, blurred vision, and some great deal of body pain. Approximately 2145, I notice that I was having trouble breathing and began itching profusely. I grabbed my epi pen and gave myself an injection. I laid back on the bed and I fell asleep. The following day Tuesday February 23, 2021, I barely had energy to get up and get ready for work. I prevailed because there is nothing set in place for people who experience an delayed allergic reaction to these vaccinations. I have literally been pushing myself through my workdays because I can not afford to be off. On Sunday February 28, 2021, I notice that the rash began to spread across my body parts. My arms, neck, shoulder, upper back, behind my ears, legs, and again I figured it related to my allergies. The condition continued to get worst throughout the next week. It was several occasions I almost lost control of my vehicle because the itching sensation had hit me instantly while driving. Once I was able to pull over, I just began to scratch every area of my body. Therefore, Friday March 5, 2021, I drove myself to Hospital too seek help. I explained my situation, I was checked in, and I showed how the rash had spread all over my body. It was nothing they could do but give me IV fluid, did some blood work and Prednisone 10mg (5 tablets) and send me home without relief. I continue to suffer from this vaccination and no one has any answers to give me. My scar-less skin now looks unattractive and dark spots where there was a rash that came and went but left awareness that I once had a rash in that spot. I am scheduled to see my dermatologist today, Thursday, March 11, 2021. My appointment time is 1615. I went my employer to file a notice of the outbreak and to see what if anything that they could do. It was just a standard report and they are submitting all information to the CDC. I am a health care professional and my job requires me to stand, sit, bend, lift, push, pull and assist in all aspects of an operating room that has caused me some issues and concerns that I can not perform my duties as required due to the severely of the itching.

Client was being monitored for 30 minutes following COVID vaccination due to allergy history. At the 30 minute mark, client reported slight throat tingling and light-headedness. Client's vitals were taken by MA (see vital signs below in medical tests). Client's vital signs were deemed stable. Client was monitored for an extra 15 minutes with no worsening of symptoms and eventual resolution of symptoms. Client exited the observation area after the extra 15-minute period of own accord reporting feeling better.

Difficulty swallowing, difficulty breathing, tongue swelling, rash to neck and arms-symptoms appeared 13 minutes after the vaccine given during the 15 minute observation.

Client being monitored for 30 min. At 30 min mark, client started noticing tingles in throat, light headed.

Approx. 2 hours after vaccination patient reports tingling around the mouth, which spread to both arms and legs with numbness and weakness in legs. States hand spasmed closed and tongue swelled. Patient was at home, mother called EMS and was transported to the ER. Per patient symptoms resolved within an hour of onset. Released from ER to home per patient report.

Synptoms: patient experienced itchiness after Moderna injection. Her Oxygen saturation was 98% and HR 89. BP 134/83. Then she experienced swollen tongue and itchy tongue and dizziness.

Eye felt irritated, rubbed eye, cornea abrasion developed, developed pain went to eye dr , found to have shingles ulcers on the inside of eye lid.

Continuous under eye twitch that I noticed the evening after getting the vaccine. As of today, it has been 2 weeks. I have not experienced this symptom before and it does not appear to be subsiding.

At 10:50 am a 43 years, female complain of a Metallic taste and ear pain after receiving the vaccination Moderna. Patient has a history of Chronic Nerve pain. No known allergies noted. V/S BP 118/79, HR 77, RR 16, O2 100%. 11:15 am BP 123/88, HR 77, RR 16, O2 100%. Patient was observed for 30 minutes. Patient stated that the ear pain was a 2 out of 10, 10 being the worst pain. Metallic taste had went away. Patient was discharged with family.

Moderna COVID- 19 Vaccine EUA Pt with history of allergies and asthma and prior reaction to first dose of COVID vaccine presents to ED with numb lips and "throat tightness" after receiving 2nd dose at 1005 AM on 3/17/21. About 20 minutes following her vaccination, patient began to develop perioral numbness and mild throat tightness. She states it was similar to prior vaccine reaction, but less severe. She pre-medicated with famotidine 40mg, prednisone 30mg, and cetirizine 20mg last night and this morning, per plan from her allergist. Following development of symptoms, she was given 0.3 mg epinephrine IM in the field. Currently she denies difficulty breathing, chest pain, dizziness, fevers, chills, N/V. In ED, Given 60 mg solumedrol and 25 mg IV benadryl. Follow up evaluation with minimal improvement in symptoms at 1300. Subsequent evaluation at 1415 with new diffuse itchiness throughout body, similar throat tightness, with report of mildly more labored breathing. No rashes or increased work of breathing on exam, vitals remain reassuring. Given development of itchiness, ordered additional dose of epinephrine 0.3 mg and will continue to monitor. On re-evaluation, patient with persistent pruritus however no new or worsening throat swelling, difficulty breathing, shortness of breath. Patient did not have abdominal pain, nausea or vomiting. Patient given additional dose of Benadryl, discharged home with clear return precautions. Patient has EpiPen at home, will continue to take prednisone as an outpatient Of note, after patient received first dose of COVID vaccine on 2/17/21, patient developed similar throat tightness and perioral numbness

Started to notice some numbness in my lower lip while talking and waiting for the shot to settle in (maybe about 15-20 min in). Stayed for 30 minutes initially. Pharmacist gave me 25mg of liquid Benadryl after I experienced numbness and swelling in both lips. I waited an additional 30 minutes under the observation of the pharmacist and was given an additional 25mg of liquid Benadryl. My swelling and numbness got a little better, so I was discharged after being told to go to the ER if I experience any trouble breathing or other allergic reaction symptoms.

Initially at the 30 min mark post vaccination patient complained of itchiness all over body, mild redness noted on upper extremities and upper back. About 45 minutes post vaccination patient complained of throat discomfort. Treatment provided was adult dose Epi pen of 0.3mg , solumedrol 125mg and Benadryl 50mg. Patient taken by ambulance at 6:00pm

Within the first hour I broke out into hives all over my body and my throat, tongue and lips swelled. Went back to pharmacy took 50 mg of Benadryl orally and applied topical Benadryl.

Extreme itching little bumps everywhere including earm ear swollen loss of hearing . 2nd day still hurt. Hearing is fine still swollen

Patient had gotten her second covid vaccine this morning at 10:30. Around noon today she felt that her throat was closing but was able to eat and drink fine and without difficulties. Patient noticed about 1655 that the roof of her mouth is numb. Patient then started noticing numbness going to the left side of her face on her way home and came to the ER. She noticed the numbness to the left cheek and jaw bone. She denies numbness to her upper forehead, nose or jaw line.

Muscle soreness at injection site started @ 5 hours after injection (5pm). A few hours after that (8pm) stomach pains/cramps began. Vomited repeatedly at 10:30pm. The following day I experienced vision blurring, foggy-headedness, fatigue, chills/hot flashes, continued pain at injection site, stomach discomfort, and shakiness from the time I woke up (@ 8am) until around 6pm, then I started to feel better. By the next morning, I felt normal again.

Got such bad fatigue I literally slept for like 16 hrs. My left jaw bone hurt so bad I could bearly open my mouth.

Moderna Covid 19 Vaccine EUA I spiked a fever, felt nauseous and threw up, and I have arm pain as well as swollen lymph nodes. Also, my body feels very sore and weak. I couldn?t sleep, and I have a raging headache behind my eyes.

Rec'd Moderna vaccine on 03/23/2021 approximately 24 hours later noticed lip, cheek swelling as well as under bilateral eyes and bridge of nose. She took Benadryl and Claritin at that time with minor decrease in swelling. Approximately 48 hours after vaccination she saw her PCP a family practice MD who said it was a reaction of the Moderna shot to the Botox shot (Jeuveau) she had gotten 1 week before the Moderna vaccine.

Light headed and some blurred vision 20 minutes after shot that lasted just a few minutes then some tingling in left leg and then started to notice hives on my hands and body, also had welts on my stomach after arriving at home. all of these events took place within the first hour. now several days later I still have the hives and non stop itching even in places that I dont have hives. my over all skin on my body just feels itchy

2/9/2021 Almost instantly again, started to experience dizziness. Followed by nausea. I was extremely fatigued. The joint pain, hip, came when I got home; R hip; felt like I almost broke my hip. Lasted for at least a month. Diarrhea started same day and lasted for 3 weeks. Into the first night, entire bottom half of bottom was all hot to the touch; only bottom half. Top half was cold. So much heat was coming off my body; sweating, uncomfortable. 3/2021 Ringing in ears. My ears, I woke up and couldn't hear; roaring. I couldn't hear at work. Went to Urgent Care; steroid shot. 60% hearing loss. Went to ENT. Stated that this has been happening with COVID patients. But I never had COVID. He extended the steroids and weaned them down. Told I will have rest of my life; Meniere disease. Due for follow up.

2/9/2021 Almost instantly had nausea, dizziness, blurred vision. Lower extremities hot to touch, almost sweating. Upper extremities cold. R hip pain to the point I almost thought I broke my hip. Urgent care; steroid shot for hearing loss. ENT; stated I have Meniere's disease. Will have the rest of my life. Weeks zero appetite, diarrhea.

Worsening Tinnitus, development of pulsatile tinnitus, acute loss of hearing in left ear, loss of female menstration (first vaccine)

Circulation problems; Dehydration; Light-headed and dizziness; Nauseous; Dry mouth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CIRCULATORY COLLAPSE (Circulation problems) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Psychiatric disorder NOS since an unknown date. Concomitant products included LITHIUM and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CIRCULATORY COLLAPSE (Circulation problems) (seriousness criterion medically significant), DEHYDRATION (Dehydration), DIZZINESS (Light-headed and dizziness), NAUSEA (Nauseous) and DRY MOUTH (Dry mouth). At the time of the report, CIRCULATORY COLLAPSE (Circulation problems), DEHYDRATION (Dehydration), DIZZINESS (Light-headed and dizziness), NAUSEA (Nauseous) and DRY MOUTH (Dry mouth) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company Comment: Very limited information regarding these events have been provided at this time. No further information is expected.

left neck spasm; felt uneasy; slight pain under sternum; fatigue; pain in her left knee; trembling in her upper body; face became a bright red; heat in her body; weakness in arms and hands; bed bound; pain in her lower back over kidney area; her body would be drenched in sweat mostly around heart and sternum area, she could splash; injection site started having pain; her injection site started having pain, it swelled up; Had skin eruptions like a boil on her right uper buttock; the boil was thought to be cellulitis and she was given a topical antibiotic; vomiting; racing heart; facial numbness and tingling; nausea; hard time breathing; shortness of breath; hives were on her upper back and under hips; she was covered in hives from, they covered her chest in a "Vshape; cough; burning sensation in her mouth; mouth was dry, tongue was thick and full, no salivation; Disoriented; began to feel very very thirsty; drinking 1 liter of water; felt pins and needles down her arms; numbness like pins and needles on injection site and neck; and while laying in bed, she felt like she was driving a race card; could not sleep; was going to pass out; high blood pressure; "She had a spot appear on her right leg and a ultrasound of her leg was performed to verify if a blood clot had developed (clot was not diagnosed)"; twitches in her abdomen, where her abdomen would cramp up; fallen down a short flight of stairs; felt like she could not move her limbs (elbow to fingers, knees to toes),limbs felt like they were frozen and paralyzed; dizzy; vertigo; migraine, lightheadedness, ringing ears, cloudy vision and headache; felt like as if someone was sitting on her chest; had a crawling sensation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRESYNCOPE (was going to pass out), CELLULITIS (Had skin eruptions like a boil on her right uper buttock; the boil was thought to be cellulitis and she was given a topical antibiotic), PERIPHERAL PARALYSIS (felt like she could not move her limbs (elbow to fingers, knees to toes),limbs felt like they were frozen and paralyzed) and DYSPNOEA (hard time breathing; shortness of breath) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Bradycardia and Hives (Patient recalls 20 years ago; she had hives.) in 2001. Concurrent medical conditions included Migraine. Concomitant products included RIZATRIPTAN for Migraine. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PERIPHERAL PARALYSIS (felt like she could not move her limbs (elbow to fingers, knees to toes),limbs felt like they were frozen and paralyzed) (seriousness criterion disability), DIZZINESS (dizzy), VERTIGO (vertigo), MIGRAINE (migraine, lightheadedness, ringing ears, cloudy vision and headache) and CHEST DISCOMFORT (felt like as if someone was sitting on her chest; had a crawling sensation). On 01-Mar-2021, the patient experienced ABDOMINAL PAIN (twitches in her abdomen, where her abdomen would cramp up) and FALL (fallen down a short flight of stairs). On 02-Mar-2021, the patient experienced PRESYNCOPE (was going to pass out) (seriousness criterion medically significant), RASH MACULAR ("She had a spot appear on her right leg and a ultrasound of her leg was performed to verify if a blood clot had developed (clot was not diagnosed)"), HYPERTENSION (high blood pressure), INSOMNIA (could not sleep), PARAESTHESIA (felt pins and needles down her arms; numbness like pins and needles on injection site and neck) and RESTLESSNESS (and while laying in bed, she felt like she was driving a race card). On 03-Mar-2021, the patient experienced DISORIENTATION (Disoriented) and THIRST (began to feel very very thirsty; drinking 1 liter of water). On 04-Mar-2021, the patient experienced ORAL DISCOMFORT (burning sensation in her mouth; mouth was dry, tongue was thick and full, no salivation). On 05-Mar-2021, the patient experienced DYSPNOEA (hard time breathing; shortness of breath) (seriousness criterion medically significant), URTICARIA (hives were on her upper back and under hips; she was covered in hives from, they covered her chest in a "Vshape), COUGH (cough), HYPOAESTHESIA (facial numbness and tingling) and NAUSEA (nausea). On 07-Mar-2021, the patient experienced PALPITATIONS (racing heart). On 10-Mar-2021, the patient experienced VOMITING (vomiting). On 11-Mar-2021, the patient experienced CELLULITIS (Had skin eruptions like a boil on her right uper buttock; the boil was thought to be cellulitis and she was given a topical antibiotic) (seriousness criterion medically significant). On 12-Mar-2021, the patient experienced HYPERHIDROSIS (her body would be drenched in sweat mostly around heart and sternum area, she could splash), VACCINATION SITE PAIN (injection site started having pain) and VACCINATION SITE SWELLING (her injection site started having pain, it swelled up). On 13-Mar-2021, the patient experienced BACK PAIN (pain in her lower back over kidney area) and BEDRIDDEN (bed bound). On 15-Mar-2021, the patient experienced MUSCULAR WEAKNESS (weakness in arms and hands). On 17-Mar-2021, the patient experienced PYREXIA (heat in her body). On 21-Mar-2021, the patient experienced ERYTHEMA (face became a bright red) and TREMOR (trembling in her upper body). On 30-Mar-2021, the patient experienced FATIGUE (fatigue) and ARTHRALGIA (pain in her left knee). On 01-Apr-2021, the patient experienced CHEST PAIN (slight pain under sternum). On 02-Apr-2021, the patient experienced MUSCLE SPASMS (left neck spasm) and MALAISE (felt uneasy). At the time of the report, PRESYNCOPE (was going to pass out), CELLULITIS (Had skin eruptions like a boil on her right uper buttock; the boil was thought to be cellulitis and she was given a topical antibiotic), PERIPHERAL PARALYSIS (felt like she could not move her limbs (elbow to fingers, knees to toes),limbs felt like they were frozen and paralyzed), DYSPNOEA (hard time breathing; shortness of breath), RASH MACULAR ("She had a spot appear on her right leg and a ultrasound of her leg was performed to verify if a blood clot had developed (clot was not diagnosed)"), DIZZINESS (dizzy), VERTIGO (vertigo), MIGRAINE (migraine, lightheadedness, ringing ears, cloudy vision and headache), CHEST DISCOMFORT (felt like as if someone was sitting on her chest; had a crawling sensation), ABDOMINAL PAIN (twitches in her abdomen, where her abdomen would cramp up), FALL (fallen down a short flight of stairs), HYPERTENSION (high blood pressure), DISORIENTATION (Disoriented), ORAL DISCOMFORT (burning sensation in her mouth; mouth was dry, tongue was thick and full, no salivation), URTICARIA (hives were on her upper back and under hips; she was covered in hives from, they covered her chest in a "Vshape), COUGH (cough), HYPERHIDROSIS (her body would be drenched in sweat mostly around heart and sternum area, she could splash), BACK PAIN (pain in her lower back over kidney area), MUSCULAR WEAKNESS (weakness in arms and hands), ERYTHEMA (face became a bright red), MUSCLE SPASMS (left neck spasm), INSOMNIA (could not sleep), BEDRIDDEN (bed bound), PARAESTHESIA (felt pins and needles down her arms; numbness like pins and needles on injection site and neck), RESTLESSNESS (and while laying in bed, she felt like she was driving a race card), THIRST (began to feel very very thirsty; drinking 1 liter of water), PALPITATIONS (racing heart), TREMOR (trembling in her upper body), CHEST PAIN (slight pain under sternum), MALAISE (felt uneasy), VACCINATION SITE PAIN (injection site started having pain), VACCINATION SITE SWELLING (her injection site started having pain, it swelled up), FATIGUE (fatigue), VOMITING (vomiting), PYREXIA (heat in her body), ARTHRALGIA (pain in her left knee) and NAUSEA (nausea) outcome was unknown and HYPOAESTHESIA (facial numbness and tingling) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Blood pressure measurement: increased (High) increased. On 02-Mar-2021, Electrocardiogram: unknown (Inconclusive) unknown. On 02-Mar-2021, Heart rate: increased (High) increased. On 02-Mar-2021, Ultrasound Doppler: unknown (Inconclusive) result unknown. On 06-Mar-2021, Blood pressure measurement: increased (High) increased. On 06-Mar-2021, Electrocardiogram: normal (normal) Tests came back fine. On 06-Mar-2021, Heart rate: 110 (High) increased. On 06-Mar-2021, Oxygen saturation: 90 (Low) decreased. On 06-Mar-2021, Ultrasound scan: normal (normal) The tests came back fine. On 07-Mar-2021, SARS-CoV-2 test: negative (Negative) negative. On 18-Mar-2021, Blood pressure measurement: normal (normal) normal. On 18-Mar-2021, Electrocardiogram: unknown (Inconclusive) unknown. On 18-Mar-2021, Heart rate: 85 (High) Pulse was a bit higher than her normal.. On 01-Apr-2021, Fibrin D dimer: unknown (Inconclusive) result unknown. On 01-Apr-2021, Ultrasound Doppler: unknown (Inconclusive) result unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Per report, the patient had a skin eruption which was thought to be cellulitis at the clinic. Treatment included intravenous infusion with epinephrine, naltrexone, diphenhydramine, rizatriptan, naproxen sodium, TEA, a nerve supplement, and topical antibiotics. She was discharged home with EpiPen, prednisone, and famotidine. On 01 April 2021, the patient felt like she had a blood clot and received an EKG, D-dimer test, and ultrasound of the heart and lower limbs. On 07 April 2021, the patient reported feeling energetic. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Facial swelling, orbital edema, blurred vision in right eye, red rash in neck, malaise, fatigue, and headache I took Benadryl 25mg Q6hrs on 1/1 and 1/2/21. When my vision became blurry I went to an urgent care clinic on 1/3/21

Patient reported tinnitus post vaccination, denied dizziness or lightheadedness. Drank water and was observed, after 15 minutes felt better and was discharged

Since I got the vaccine, my left eye bothers me in way that I have a watery, itching , red eye & feeling of sand on it. It bothers me more at night, it started at the same night of vaccination (1/4/21). Today is 1/7/21 and still bothering me.

The employee kind of tasted the vaccine then had tingling sensation on the sides of her tongue. After several minutes, her sides of tongue was numb. After 4 hours, she felt fine but had that tingling sensation on the side of her tongue still

7 days after injection, site became swollen, red, warm and itchy. Remained red and warm for 1-2 days. Also, 2 other areas within 3 inches, on arm became red and warm. Eyes became itchy, blood shot, irritated, 3 days after vaccination.

Headaches, neck spasm with blurred vision at times started 3 days after administration of Moderna COVID-19 Vaccine EUA.

15 post vaccination started to complain of her lips tingling. It progressed to itchy eyes and started getting a little itchy all over. Her lips went from feeling itchy to feeling waxy. Gave benadryl at 5;15 pm. Patient started felling less itchy and lips were feeling a little better at 5:30. continues to monitor patient until 5:45pm patient stated she was feeling better and felt comfortable going home. Patient left clinic at 5:50pm. Called and checked on patient at 7:00pm and she stated all symptoms were gone that she was just tired from the benadryl

injection site at upper deltoid, Pain in mid shoulder with ROM above >90 13:30, at 15:30 pain increased in left shoulder with AROM. Shoulder and back warmth. Numbness in left cheek and left lip. All resolved, mild with arm pain with turning apply force c Narrative:

At 3pm, I started to have a small allergic reaction. Symptoms started with sweaty palms, my tongue felt strange, my body felt weird particularly from my knees to my toes and I was easily winded moving around. Symptoms slowly progressed until I went to the dr and was prescribed prednisone and benedryl.

Chills and body aches approximately 8 hours vision changes approximately 30 minutes, headache ongoing for several days now, fatigue

Swollen/ tingly feeling in lips, tongue and cheeks as well as tingling in legs and arms, started about 1 minute after injection. Was monitored on site by EMT for 45 minutes. It did not seem to get much worse so, went home and took Benedryl. About 1 hour later symptoms started to subside. Next day, sore arm and still have a strange feeling in my tongue and lips. Teeth feel a little numb or swollen. Feels like I have lost some of my sense of taste on my tongue.

Patient called and stated that left side of her face turned red and had a small rash. She has some sort of difficulty breathing and felt her tongue somewhat swell up. I informed her to take benadryl 50mg right away and seek medical emergency at urgent care or ER.

I had throat & tongue swelling in the 15 mins after 1st covid vaccine/moderna..... EMS walking me out of school to ambulance & I passed out on sidewalk. And even I could not talk due to throat and tongue swelling and was getting weak. I was checked BP , it was over 150. I was transported to LG Alleghany - I received 1 epipen at the ambulance and another epipen in the ER. total got 2 Epipens. --- heart racing & shaking all over -- At the ER, took x-ray on lung and thorat , did EKG, and got Benadrly then slept for 40 mins or 1 hour.

Flushing, lump in throat, body aches , fatigue, sore arm, increase BP , increase heart rate after 10-20 mins post vaccine, then mild headache , nausea, metallic taste, dizziness for 3 days , then developed swollen lymph nodes on left supra clavicular area , fever, chills , extreme fatigue on day 4. Increase BP for a week, my BP runs low -my baseline.

Severe shoulder pain between 20-36 hours post injection. Taste of metal in mouth intermittent x 2 days. Moderate lethargy/fatigue intermittent days 2-7 post injection

Tongue and lips started to feel "prickily" and then became numb. The next two or so days pain in my right kidney area.

She reports on 12/28/2020 feeling fine. On 12/29/2020 she noted a lump at injection site with swelling, she reports extreme body aches through 1/1/2021 to the point that if she would have been scheduled to work that she would have not been able to perform her job duties. She denied any fever or chilling. She reports that the vaccine gave her side effects similar to when she had the Covid but more severe. She reports on 1/7/2021 that her sense of smell seems like it is not as it was after receiving the vaccination.

Due to clients extensive history of allergies, client was placed in 30 minutes post vaccine observation by EMS. It was there client started experiencing " tingling and scratchy throat." Client's VS were taken at 1148 and as follows: BP 144/103, Pulse 85, O2 Sat 100%-EMS took over care and continued to monitor patient. At 1159 BP has increased to 158/95. At 1200 50 mg Benadryl IM was given in RDM. At 1204 BP had decreased to 148/86. EMS made the call to transport the client to Hospital for further evaluation and treatment.

20 seconds post vaccine: Flush and dizziness 5 mins post vaccine: tingling tongue, flush, dizziness 15 min post vaccine: symptoms as above, tingling below knee to feet 30 min post vaccine: symptoms as above, facial/jaw tingling/felt swollen, ears hot/swollen -- took diphenhydramine 25mg 45 min post vaccine: tongue and face started to feel better, tingling moved to back of throat with mild difficulty swallowing 60 - 90 min post vaccine: took another 25 mg diphenhydramine and 10mg claritin. Symptoms started to subside 3 hours post vaccine

Severe soreness, redness, bruising, swelling to injection site that started the day after vaccine was administered. Diagnosed with cellulitis and treated with antibiotics. Also fever up to 104.2 that stared about 26 hours after vaccine was administered with eyes burning, chills, extreme fatigue, clear runny nose and some cough. Body aches. Fever up and down for 9 days with fatigue and body aches.

Reported lip numbness, weird feeling in throat shortly after vaccine (past 15 min. observation period). Lips remain numb today, the morning after. Also fever and body aches.

Swelling and tightness of the neck and under the tongue that began acutely 25 hours after injection was given on the same side as injection site.

Pt reported feeling ill after returning from lunch, visibly shaking, heart racing, sweating, feeling like something catching in her throat, numbness in fingertips and lips. Placed in supine position with legs elevated, administered Benedryl 25mg IM at 1359. BP 148/96, HR 118, O2 sat 98%. Dr. in room, checked mouth and throat - noticed redness but no swelling. Used alcohol under nose, pt did not feel any better and was reporting that she felt like she was spinning. @1416 BP 140/90 Blood glucose check, 116, HR 101., O2 sat 99%. Pt observed and remained in supine position. @1441, pt reported feeling better, BP 128/79, HR 88, skin warm and dry. Assisted to a standing position. Reported spinning had stopped and was able to ambulate. Pt sent home to rest with instructions to call if worsening or call EMS.

Pt woke with swelling of lips and face morning after first injection. 1 week later had severe redness, swelling, and heat of ears

I felt most of the symptoms i had when i had covid in april. My legs were sore and when i stretched it felt so tight. my head hurt so bad the day after the shot pounding headache and sensitivity to light. the first feeling i had was at like 2am i woke up with a very sore throat felt like i had strep to the point where i went to the mirror with a flashlight to see if i had spots on my throat. I took tylenol to help with the pain. by tuesday i still felt very weak and was sleeping alot like when i had been sick. I took off thursday from work because i still felt weak and hopeless. when i was sick with covid i was very depressed as i got better. I started feeling more like my self today, friday.

Moderna COVID-19 Vaccine EUA . Day of vaccine, soreness and swelling at the point of injection (upper left arm). Headaches and low-grade fever (99.8 F to 99.0 F) continued for 6 days (current). Headaches were more intense in sensation with periodic sensitivity to sound in the first 24 hours. Arm pain and swelling dissipated after approximately 36 hours.

Fever (102) on day of vaccine. That evening reports sore at injection site but also systemic symptoms of chills, body aches, "skin and eyes hurt" Next day nausea and abdominal pain. Per patient, she felt exactly like she did when she had COVID. Did get tested again and tested negative. Now systemic reaction resolved and has some localized redness and swelling at injection site. Patient called to have us report reaction to VAERS

"Moderna COVID-19 Vaccine EUA" -Received vaccine at 8:00am. Felt fine till approx. 3:30pm at which time started becoming feeling exhausted and yawning excessively. Began aching all over especially in areas of previous injuries. Took Tylenol 1gm for aches. 1 hour later shivers and checked temp that was 99.5 orally. At 8:00pm symptoms intensified along with lightheadedness and burning feeling throughout trunk/Chest. Started vomiting around 10:30pm. Vomited x2. Headache, shivers, aching, excessive yawning lasted till around 5:00am which at that point was able to keep Tylenol down. Symptoms from that point on subsided over time. Very tired and sore for the next 12 hours. Jaws sore from the excessive yawning remain.

on 1/15/21 woke with a rash all over my face and very itchy, took Benadryl and went on with my day around 9pm that night my face was swollen and left eye was swollen shut. Went to ER and was told a possible reaction to the Covid vaccine and was given a oral steriod in the er that night and sent home with a script for a steriod for 3 days. Went home and woke up (1/16/21 that morning 3 times as I had to change my clothes as I was soaking wet in sweat. Changed my clothes and took my meds and as the night went on the swollen in my face got worse and took more Benadryl. Sunday 1/17/21 swollen no better and the rash is worse. I took it easy and took meds.. Monday 1/18/2021 woke up with a very swollen face and very itchy. Face very warm to the touch (No fever 97.9) Called my primary Doctor and she told me to come over asap as the I was feeling any better and getting worse. Both eyes are almost swollen shout and my face is very hot to the touch. Doctor extended my dose of steriods and gave me a script for Pepcidfor 7 days.

About 30 minutes after the vaccine was administered, my mouth began to feel strange. Had a slight metallic taste to my mouth and my mouth also felt a little dry. About 10 minutes later, my mouth started to feel slightly numb. Then my whole face, neck, and inside my mouth felt slightly numb. Not completely numb. I was still able to breath and swallow just fine. The numb feeling lasted close to 24 hours.

Woke up at 3pm the following day burping the taste of boiled eggs. No boiled eggs had been eaten and still burping the boiled egg taste at 10pm.

Lips felt swollen and chapped night of vaccine. Didn't think anything of it. Woke up next morning lips still swollen and chapped feeling...small bumps around my lips. Swelling, itching and dryness continued through day. Used vasoline for dryness and took benadryl for itching and swelling.

12/31/20 body ached, chills, fever, fatigue, sore throat 1/1/21 reported tongue/throat swelling- relieved with Benadryl and Allegra

large welt approximately 2x3 inches; Neck, arm and face were swollen; Too painful and hot; Headache; thought maybe it could have been a sub Q dose; pretty severe lymphatic response; Incredibly red at the injection; Incredibly painful at the injection; Incredibly swollen at the injection; weird taste in mouth; sore throat, like a weird sore throat; A spontaneous report was received from a nurse regarding a female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced incorrect route of product administration, urticaria, swelling, taste disorder, lymphadenopathy, injection site erythema, injection site pain, injection site swelling, oropharyngeal pain, headache, and injection site warmth. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Lot number 039KZ0A) on 31 Dec 2020 in the right arm for prophylaxis of COVID-19 infection and experienced incorrect route of product administration when it might have been given subcutaneously. On 31 Dec 2020, after about an hour or two after receiving the vaccine, she experienced a pretty severe lymphatic response. Patient stated after she received the vaccine, it left a weird taste in her mouth and got a sore throat, like a weird sore throat. On 01 Jan 2021, her arm was incredibly red, painful and swollen at the injection site. A large welt approximately 2x3 inches developed. It was significantly raised, and she could not touch it because it was too painful and hot. She also developed a headache. On 02 Jan 2021, the site grew to 4.5x4 inches and was still hot and raised. The patient stated she went to the emergency department because she was concerned that she might have cellulitis. She was told to monitor it. On 05 Jan 2021, the welt was the size of a quarter, and the headache resolved. On 08 Jan 2021, the welt was the size of an eraser. She stated she felt better. Treatment for the event included acetaminophen and ibuprofen. Action taken with mRNA-1273 in response to the events was not reported. The events, lymphadenopathy, injection site erythema, injection site pain, injection site swelling, injection site warmth, taste disorder, oropharyngeal pain, urticaria, and swelling, were considered unknown. The event, incorrect route of product administration was resolved on 31 Dec 2020. The event, headache, was considered resolved on 05 Jan 2021. The reporter did not provide an assessment of the event, a pretty severe lymphatic response, arm is incredibly red, painful and swollen at the injection, left a weird taste in my mouth, sore throat, large welt approximately 2x3 inches, raised, could not touch too painful and hot, neck, arm and face were swollen and a headache.; Reporter's Comments: This case concerns a female patient, who experienced non-serious unexpected events of urticaria, swelling, taste disorder, oropharyngeal pain, and non-serious expected events of injection site warmth, lymphadenopathy, injection site erythema, injection site pain, injection site swelling and headache. This also refers to a case of incorrect route of product administration for mRNA-1273 (lot # 039KZ0A). However, there were no reported AEs associated with this case of incorrect route of product administration. The event of taste disorder, oropharyngeal pain, lymphadenopathy, injection site erythema, injection site pain, injection site swelling occurred after 1 day after mRNA-1273 (lot # 039KZ0A) administration. The event of urticaria, swelling, injection site warmth, and headache occurred after 2 days of mRNA-1273 (lot # 039KZ0A) administration. The treatment included Tylenol and Motrin. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient felt shaky, hot and racing heart with a dry mouth. Symptoms subsided with in 15 minutes and she felt much better. Did advise her to follow up with her physician and if signs and symptoms develop or worsen she should seek immediate medical attention.

Woke up at 6 am on January 15th feeling extremely fatigued (more than normal). Around 10:30 am I began feeling extremely flushed (no fever although my temperature was elevated for my normal temp - usually 97.6 and it was 98.7) and nauseated. My whole body started to ache around 11 am and I had a hard time staying awake. When I left work around 4:00 pm I went home and slept for the rest of the day and until 11:30 pm that night. I got up and had a snack and then went back to bed. Slept all day January 16th due to a horrible headache and fatigue. Woke up feeling a bit better Sunday although I still had a headache and some fatigue. Monday I was doing better. Later in the day on Monday, January 18th my right eye started hurting and feeling irritated. Then on Tuesday, it started getting a little pink. On Friday I had a puffy red eye. I saw a doctor online on Saturday, January 23rd and I was given eye drops for conjunctivitis.

Member is feeling like her tongue is swelling up. No visible swelling. Observed while in gurney. Vital signs taken while laying down and when sitting up. Water provided. Monitored from time after vaccination to 5pm. Member felt swelling was going down and was fine to go home.

Body ache chills fever at 2:00 on 1/22/2021 that lasted until 6 pm with itching numbness mouth. The itch mouth and numbness of upper lip has not resolved as of today 1/24/2021 at 1530

On January 9 there were significant redness and swelling at the vaccination site as well as fatigue. The redness And swelling decreased slowly but continued for about five or six days. As the redness went down itchiness increased. By the seventh or eighth day there?s no longer any sign of redness or symptoms. On the morning of January 19 the redness at the vaccination site returned and by the evening redness warmth and swelling had increased. After a telehealth visit I was advised to take Benadryl that night which I did. The following morning after a cup of coffee which I have ervery day, I had the onset of intermittent palms and soles of my feet sweating and later in the morning had jaw/mandible and tongue tingling. This tingling lasted about 10 to 15 minutes. On January 21 the redness and swelling started to go down and in the evening I had three hives appear, one at a time on my back and buttock. They only lasted a short period of time and we?re gone by the time I went to sleep. On January 22 I had one more short episode of tingling of the mandible which lasted a short period of time . Over the next several days the redness and swelling went down and as that happened the itchiness returned and is still mildly present today January 24. There is no longer any redness or swelling though

1537 spoke with provider concerning her medical history, history of anaphylaxis to 3 different medications 1545 vaccinated 1620 Code 1 called on radio and provider proceeded to evaluate 1622 Pt evaluated and had slightly thickened tongue, feeling of throat fullness, Mallampati 3, no stridor, vital normal 1627 EMS arrives 1630 loaded into ambulance and transported to Hospital

Lump felt in throat, flushed face and ears (hot to touch), slightly swollen and numb lips (especially upper lip). Symptoms started about 20-25 min after injection. Took Benadryl orally and symptoms resolved within about an hour or slightly longer.

About 30 min after I received the vaccine in my left arm I began to have swelling on the left side of my mouth and tingling throughout my left arm. Took Claritin and eventually the swelling and tingling went away within an hour -hour and a half. That following Tuesday night around 7pm I had the swelling in my lip on the left side again and throughout my chin. This time it took longer after Claritin I felt it still even as I went to bed around 9. When I woke the next morning at 5:30 the swelling was down but the pressure in my chin was still present but did go away completely through the morning.

Tingling of palate. started 5-7 min. after receiving the vaccine Difficulty breathing, tachicardia, hypertension lasted about an hour- hour and half but hard to say until benadryl kicked in. TReated in ED with IV benadryl and pepcid . I left the hospital 5 hours later with normal vitals of heart rate in the 60's and b.p. 112/62

Within 10 minutes horrible headache and tasted metallic taste. In an hour my face and tongue was numb. The headache got more and more extreme The next morning people at work noticed I was slurring my words. Felt like crap full body aches and extremely tired. Went to the hospital and it was determined I have bells palsy. Still have headache and facial paralysis

Per summary of primary hospitalist. Pt admitted for acute hypoxic respiratory failure requiring mechanical ventilation secondary to angioedema from Moderna COVID-19 vaccination. Pt presented with a chief complaint of tongue and facial swelling approximately 10 minutes after receiving first dose of the vaccination. She did not respond to Benadryl or IM epinephrine. She was admitted to ICU and intubated. She was started on IVsteroids, famotidine and diphenhydramine. Swelling gradually improved and she was successfully extubated. Her hospital course was complicated by steroid-induced hyperglycemia requiring insulin.

Fine for 15 minutes during wait time. During drive home, about 30 minutes after, I felt a sort of ripple of energy across the right side of my face. My throat did not close, but it clenched or got tight and my tongue seemed to tense. Before I had time to think about that, I had a surge of adrenaline which left me a bit startled. The tongue and throat tightening happened without an adrenaline surge approximately 4 more times. I lost feeling in my left arm and felt lightheaded. This lasted about 30 minutes, after which I felt fine. I experienced sharp stabbing pains in hands, feet, pelvis and fingers, which are still present 48 hours later. At 24 hours post-vaccine, I felt chills and developed muscle aches and a low fever, which are still present at 48 hours post-vaccine.

Tongue started to swell, tingling lips & heart racing. Reaction lasted for 5-10 mins. Didn?t notify EMS

Headache, nausea, body aches, chills and fever (highest 101.1) began around 1am 1/26/21 and continued throughout the day, fever finally breaking around 7pm that night. I woke the following morning 1/27/21 at 7:20a feeling better, only slightly tired. I was awake about 30mins when my husband reported I stated I felt very dizzy while standing in our kitchen, he states I started walking over to our living room when I fainted and fell face first into the side of our sofa. He stated I came too about 20-30 seconds later. After awaking my hearing was muffled and my arms were very tingly for about 3 mins. I felt completely exhausted and slept for a few hours, remaining very fatigued the rest of the day. Today, 1/28/21, I woke up feeling tired but tightness to base of my head and neck, no other symptoms.

0 - 30 minutes: Dizzyness, mild bronchial tightening, aching at location, aching and cold sensation on dorsal 2-3 tarsal hand. 30min to 4 hours: increase in sourness. No decrease in other symptoms. 4 - 6 hours: small rash at injection site developed, swelling, hardness, and inflammation developed at the injection site. Increase in nerve ache at the hand, now including the wrist. A decrease in dizziness. No more bronchial tension. 6 - 12 hours: Soreness at injection site increased. Nerve pain with cold, ache, and numbness through the left anterior arm and left anterior and posterior forearm with weakness in the left hand. Swelling on the lymph nodes in the Left arm pit. 12 - 22 hours: Increased swelling of the left auxillary lymph nodes with associated pain. Large node bulge is developing. Inabiility to fully rest arm at side. When anything less than 15 degrees (addcution or at rest) the nerve pain and lymph node pain increases to the point of mild nasea.

Lip swelling, numbness and slight discomfort. I took diphenhydramine 25mg with no effect. No other signs or symptoms of allergic reaction (no hives/rash, no swelling in any other areas). At the time of this reporting , the swelling has improved a lot. I read a possible correlation with lip filler recipients. I did receive lip filler approximately 1 to 1.5yrs ago.

Lower right eye, where I received facial filler in November 2020, is grossly swollen and partially obstructing my field of vision. It?s painful, swollen and looks bruised. I also received expected side effects: fever, painful swollen joints, full body aches, migraine.

one evening of MILD facial loss of control on one side / numbness on that side of my face--similar feeling to several hours after receiving shot(s) of dental novacaine a bit of a droopy smile on one side the night of the shot, though when I smiled for someone a few hours after the shot, both sides of my smile were even My mother noticed that one side of my face was droopy though when I spoke with her over video conferencing. But I noticed the next day that I had better control of my facial muscles on the left side. The night of the shot, I also felt some numbness/mild pain around my left ear and on the tip of my nose and on my cheek and a new sensation (numbness) on the left side of my brain. Also that night though, I sang a short song and had a loss of control of the tune--like my voice was really changing (unusual). Now, I feel some barely perceptible numbness on that same side of my face sometimes but really feel fully capable of everything and like this doesn't really matter except to let others know that it can happen. I am very happy to be vaccinated and want the second shot if it's okay!!!

About 5 minutes after vaccine, rash started to form near site. Then I felt like my body was burning from the inside out, sweating, hives, face turned red, itching all over the body, tongue tingling . I was sent by ambulance to the ER.

FLUSHED SKIN BACK OF TONGUE FEELS SWOLLEN 1100 PATIENT GIVEN BENADRYL BY MOUTH. AFTER 30 MINUTES, PATIENT FELT OK, AND LEFT WITH HUSBAND WITHOUT OTHER COMPLAINTS

Chest Pain-ongoing tongue tingling- lasted 1 week Lightheaded- ongoing dizzyness - ongoing arm weakness and soreness- ongoing

Allergic reaction, initial encounter Left arm heavy numb to wrist Throat numb felt as if swelling Face numb eye pain floating spots nausea headaches Cold Rapid heart beat monitor breathing and BP rates Went to hospital via EMS

Left arm became extremely sore and achy around 6pm on 1/26/2021. I my head and body started feeling achy around 7:30 pm on 1/26/2021 so I went to bed. I woke up around 2am on 1/27/2021 with sore throat, severe head and body aches, stiff neck, chills, and took my temp it was 102.8. I had a fever off and on through 1/28/2021. In addition to those symptoms, on 1/28/2021 my teeth started hurting and 1 lymphnode in my right neck next to my jaw starting swelling and getting very hard. It was very painful. On Friday 1/29/2021 I felt a lot better and resumed normal activity. On Saturday 1/30/2021 at around 3pm my lymphnode started swelling off and on again, my body felt achy with it, I also, developed slight shortness of breath, a dry cough, and a slight headache. I took my temp and it was 99.9. This is still continuing today 2/2/2021.

Within 5 minutes, I felt weird and light headed. My blood pressure spiked, temperature spiked to 101, heart rate was elevated and continued to be elevated for about 12 hours, and there was a rash across my chest and upper arms. On 1/14, I was extremely tired. On 1/15, I had a sore throat, headache, and still slightly tired. As the days went on, the cold symptoms got progressive worse. Extremely congested, runny nose, extremely painful headache, coughing up pflegm, sore throat, etc. On Wednesday, 1/20 I had a fever of 101. I had these cold symptoms for a week and a half and that was when I called my doctor. She gave me an antibiotic. I was on the antibiotic 1/26 - 1/30. Today is 2/4 and I'm still coughing. Something weird also happened, smells changed. My coffee smelled awful and other things seemed extremely strong.

15 mins after receiving the vaccine, patient experienced light headedness and dizziness and felt tongue swelling that lasted approximately 1 hour and then she was fine.

Anaphylaxis reaction; Angioedema; Shortness of breath; Wheezing; Fast heart rate; A spontaneous report was received from a physician concerning a 44-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylaxis reaction, angioedema, shortness of breath, wheezing, and increased heart rate. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021 at 18:00, approximately 10 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 20 Jan 2021, approximately 10 minutes after receiving her injection, the patient began to have tongue swelling. She was given diphenhydramine and epinephrine by epi pen. She went to the emergency room where she displayed symptoms including a fast heart rate, wheezing, and shortness of breath with an angioedema or anaphylaxis like appearance. She was given more epinephrine, famotidine, scheduled diphenhydramine at 50 QAs intravenously (IV), IV steroids, was intubated and placed on a ventilator. She was on the ventilator for approximately 18-20 hours following admission. She eventually responded to a high dose of dexamethasone. She was also given duonebs for her shortness of breath, regular sedation for the ventilator, and a dose of ketorolac. Consent was given for Safety to follow up. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events were unknown at the time of this report.; Reporter's Comments: This case concerns a 44 year old female patient who experienced a serious unexpected event of Anaphylactic reaction. The event occurred approximately 10 minutes after first dose of the study medication administration. She was treated with epinephrine, famotidine, diphenhydramine, IV steroids, intubated and placed on a ventilator. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Patient received Moderna Covid 19 vaccine on 02/04/21. Patient reported experiencing twitching in right eye the night of 02/04. Patient had swollen face and little difficulty in swallowing upon awakening today (02/05/21). MD treated patient with steroid injection and Benadryl and recommended not to get second dose.

My eyes began swelling roughly 36 hours post injection and the edema went down into my right cheek. It resolved with Zyrtec two tablets bid x 1 day.

Right side of my tongue felt tingly and numb as soon as I arrived to my car about a 2-3 minute walk after 15 minute observation. It has been 23 1/2 hrs since vaccine and feeling is just going away.

Severe 9/10 scale symptoms Migraine like headache, photophobia . Muscle aches, Most severe for first 18 hrs. 36 hrs duration. Skin was hypersensitive to touch,painful. 24 hrs duration Fever 101.5 - 103.2 . Didnt take any meds to reduce fever or above symptoms. Fatigue. No energy for anything other than getting up to the bathroom. Slept off and on for 36 hrs.. Brain fog!! Still have it after 4 days,and moderate fatigue.

1st shot, redness, itching starting on R arm within 3 days, spreading to rest of the body for 4 days, Took Benadryl, and 1 tylenol at night. 2nd shot, systemic itching and redness/ flushing, hives, eyes bloodshot and blurry ( like when I had covid 11/3/20), profuse sweating within 3-4 hrs after the shot lasted for 24 hrs. Other symptoms incl loss of taste for 12 hours, chills, bone and muscle aches, temp 100.7, headache, fatigue x 2-3 days. Took 1 tylenol at night.

10 minutes post second COVID vaccine, reported "floaters in vision," mild central chest pressure and elevated blood pressure 200sys/100dias and felt her "heart racing" pulse measured 101. after monitoring for approximately 30 min we decided to send to ER.

Bilateral ringing in ears. Started 8 hours after 2nd dose of Covid Vaccine. Lasted 12 hours. No history of same. Reported as peer had similar side effects. No dizziness

Mild dizziness started within 5 minutes. Within 20 minutes my tongue started to swell, but only the front to middle part, not the back part. I was still able to breathe. After 25 minutes, I was unable to stand and nearly passed out twice trying to get to some place safe. I could not verbally communicate and was lacked strength to move. I started drinking as many fluids as possible with the assistance of family. Symptoms began to subside after 3 hrs. After 4 hrs, I regained strength and was not dizzy if I stayed in place. I continued to push fluids and rested. I needed to be careful not to drink anything too cold as i would develop the chills. The next day, there was no dizziness but I was very groggy. I continued to push fluids. I would develop a headache if I did not drink at 16 oz every hour. The following day, I was still groggy, but was functional and felt okay to drive.

Patient reported bilateral numbness in fingers and feet with dry mouth. Symptoms lasted greater than 15 minutes.

Extremely dry throat, tongue felt swollen towards the back, BP 133/90, itchy hands (this was within 10-12 minutes of vaccination- called primary care physician, she recommended monitoring- Nurse gave me small dose of Benedryl which helped the symptoms- that night I ran fever, itchy feet and palms again and small bumps on my chest- day2 of vaccine- muscle aches, fever, overall flu-like feel, rash on chest still present, but not itchy- day 3- much better, low grade fever, no allergy reactions noted.

I had the vaccine around 8 in the morning, a few hours later I lost my voice. I also developed a slight headache, arm soreness and fatigued. This lasted about 3 days.

About 15 minutes after receiving the second dose of the Moderna COVID-19 vaccination my face started tingling and my tongue started to swell and feel numb. My tongue sensation subsided in about 30 minutes. It took about two hours for the tingling in my face to subside. I took Benadryl and all symptoms went away.

2/17/2021- 02/18/2021: Chills, Headache, fever, gait instability, burning feeling and pain in the injection site. 2/24/2021 Strong throat pain, nasal drip, taste loss, chills, weakness.

scratchy throat, dry eyes, skin felt like Niacin Flush, small blisters on tongue. Took Benadryl and side effects went away in about an hour. Muscle pain in injection site that shoots down arm and causes stiffness in arm. Treating with warm compress and pain meds

Headache, nausea, fatigue, light sensitivity, body ache, body feels weighed down and left arm sore where injection sight is

My left arm, where I received the shot, began hurting after a few hours. Approximately 12 hours after receiving the shot, fatigue began. Approximately two hours later, I was unable to walk, I collapsed on the floor, my heart was racing, I was sweating, my entire body went numb, and there was ringing and static in my ears. After about 20 minutes on the floor, I got back into bed. My fingers and hands wanted to curl up and not open and that lasted throughout the night. My arms and legs stayed numb all night long. At around 24 hours post vaccine, the numbness started to subside, I could open my fingers and hands, and regular flu symptoms were present (fatigue, body aches, low grade fever). I could not work the day after receiving the shot. I slept all day. I was not able to drive until around 5PM the day after receiving the shot. The second night and throughout the following day (so 36-48+ hours post shot), I had cold sweats. It is now 3 days later and I still feel terrible. I am worried about getting the second Moderna shot.

After taking the shot I had a very mild metallic taste in my tongue. After about 45 minutes later the metallic taste became much stronger. My lips felt like they were drying out, my tongue felt like it was swelling and drying out, and it felt difficult to swallow. The strong sensation only lasted a couple of minutes. It is now 7:48 PM and I still have a "very mild" case where my lips feel they are either itchy or mildly burning and my tongue still feels weird and has a very mild metallic taste. I did not have any issues with tasting anything. I also have a very mild headache.

Patient reports numerous aphthous ulcers in her mouth 2 days after getting the second dose of the vaccine. She also reported swelling in her lips and tongue but I did not observe any swelling. She does have many small shallow ulcerations in the buccal mucosa. There is no lymphadenopathy and her vital signs are all stable. She otherwise, appeared well.

within 10 minutes of vqccine patient felt throat tightness and tongue swelling up; given epi pen with some relief

Fatigue, body pain, burning eyes, felt exhausted. Hives & welts on thighs & arms started next day around noon. Had to go to Urgent Care this morning & was given Prednisone, Flamodine & Benadryl for night time.

chills, difficult maintina body heat in extremities (feet and hands), joint pain, boady aches, eye dryness, rash and welt the 4cm x 7 cm at injection site displaying swelling and heat, and itch. at 15 hour post injection started intermittent rounds of ibuprophen and acetaminophen. now at 43 hours post injections symptoms same and upper respirator and congestion and post nasal drip has started.

Pale, clammy, diaphoretic associated with vomiting and near syncope 12 hours status post vaccine. Then within 24 hours post vaccine developed burning in chest. 36 hours post vaccine severe chest pain. Described as elephant on chest radiating down left arm to left jaw associated with paleness and diaphoretic. Hurt to take in deep breath and pain worsened upon lying down. Relieved with motrin 800 mg. I continued motrin every 6 hours until I could follow up with cardiologist on Friday 01/29/21. EKG showed ST elevation in all leads. Stat echo was performed at facility. Diagnosed per doctor with acute Pericarditis. Started on Colchicine 0.6mg twice daily X 10 days. Other doctor followed up and continued Colchicine 0.6 mg x 90 days.

Persisting symptoms that resulted from the injection are: right shoulder pain, pain at right base of neck, pain behind right ear, localized headache on right side of back of head, shooting pain down right arm and joints.

I had Covid-19 in December 2020. On the following day of my first vaccine, in the middle of the night, I experienced chills, body aches. At 7am the next day I woke up feeling light headed and passed out. When I woke up I had thrown up on myself and started to hear a whooshing sound in my ears and I went back to bed. At 9am my symptoms started all over again. I live with my house maid and since I did not look well, she took me to urgent care. My BP had dropped and I was super dizzy. I got an IV drip for an hour, anti-nausea medication. My blood was also drawn and found to have underlying anemia. My urine test was negative. The pulse oximetry was fine and by the next day I slowly started to feel better.

Within hours I had cold sores covering my lips. 72 hours later, I realized that I had developed tinnitus. The injection site took more than 35 days to heal.

Aching arm < 30 minutes after shot. Swelling in neck (left side) 2-3 hrs after shot. Body aches within 6 hours. Fever, chills, and ringing in head within 10 hrs after shot. Fever up to 102.5F. Shot given 2/16 at 8:30 am. 2/18 at 1pm numbness to left side of face. Went to ED. Swelling in neck visible with movable gland. Discharged home. 2/19 numbness gone and swelling decreasing. 3/5 arm aches, swelling mild in neck, movable gland persists, ringing in head continues.

Injection site pain began approximately 2 hours following injection and continued to intensify and spread down the arm and up the neck and upper back over the next hour. A headache and intense fatigue began and I took 500mg Tylenol at that time. Approximately 30 minutes later I unintentionally lost consciousness and awoke several hours later confused and disorientated. I arose to get a drink of water and was unable to walk, falling twice within approximately 10 feet. I noticed my vision was affected as the entire room appeared to be rocking left to right even though I was holding myself still in an attempt to steady my sight and balance. I immediately went to bed and have no memories until I awoke the next morning. At that time, my vision and balance had returned to normal though the aches and pain in my arm, neck and back persisted. This pain slowly dissipated over the next 3 days.

Vomiting, fatigue, headache, dizziness, chills, low grade temp, loss of taste, difficulty breathing, rapid heart beat. The vomiting stopped yesterday. Rapid heartbeat and dizziness started within 10 mins of having the vaccine.

WITHIN 15 MINUTES, PATIENT EXPERIENCED SWELLING/NUMBNESS TO LIPS, FEELS SWELLING IN THROAT, SHORTNESS OF BREATH

Within in 20 seconds, I stated to get flushed. I felt flushed, hot in my face, and felt dizzy and my tongue and the back of my throat started tingling. Then about 30 minutes my knee (below the knee), calves and feet started to feel tingling. My jaw and ears also started tingling. EMT then took my BP, lungs were clear. I was given Benadryl and Claritin as medication. I had no shortness of breath or difficulty swallowing. I talked to my immunologist who recommended not to get the second dose. However, I subsequently feel that I have a reaction and I am extra sensitive to alcohol and certain type of foods which I did not have before.

Pt had an immediate (within 2 minutes) onset of light headedness and shaking after getting the vaccine at about 10:30 AM After about 10 minutes, she reported to me that she was feeling very shaky, chest tightness, tongue swelling and difficulty swallowing. She thought it might be anxiety and wasn't convinced it was an allergic reaction, so we decided to monitor her. I continued to monitor and she said she was starting to feel a bit better, but not well. At 11 AM, I decided to start taking blood pressure. BP readings were 11 AM 117/66, pulse 76. 11:05 122/77 pulse 69. 11:15 130/84 pulse 102 at which time pt reported not feeling well and we decided to lie the pt down and administer an Epi-Pen. 911 was called at that time, epi-pen was adminstered at around 11:18 AM. 11:20 BP 130/90, pulse 69. within minutes, EMT arrived and started to monitor pt. Pt was released at 11:40 AM refusing transport but her husband was going to drive her to ER for monitoring. Unaware of her status at this time. Will update it when I know more.

I had a visual aura seizure four days after the first vaccine. It started with minor stars/auras in the right side of my right eye and within about 5 minutes, half of my vision was gone. After resting and eating, my vision was restored and the aura stopped. A couple of weeks later I had episodes of minor facial drooping, which lasted for a few hours each.

Migraine headaches, dizziness, nausea, weakness, numbness, pins and needles, palpitations, ringing in ears, clamminess, hot flashes

Itchiness and hives all over my body including scalp, swollen eyes and forehead. Hives would multiply and get swollen if I scratched them.

Pt received the first dose of the Moderna COVID vaccine on 3/6/21. The following morning, she had moderately swollen eyes and mild dizziness. Eyes swollen since Friday after covid vaccine, BP noted to be low after taken twice. Pt went to ED and was put on Pepcid, Benadryl, and Prednisone. Pt feels the same, no improvement in the eye swelling. The dizziness is gone now. No fever, redness or pain at the injection site. Pt is swallowing and breathing without difficulty. Any treatment So Far: prednisone, benadryl, pepcid

3 to 5 minutes after the vaccine was given my tounge started to tingle and swell. Then the swelling progressed to my throat, cheeks. I advised th pharmacist about 5 min into the reaction and was told to buy benadryl and take "some". I took 50mg oral benadryl. By this time I was having trouble swallowing. I waited 10 more minutes of observation at the pharmacy. By then my lips had become numb and no effect was had from the benadryl. The pharmacist advised I go to ER or urgent care. I went to ER. I was evaluated. BP, HR, SPo2, within normal range. Respirations 25/min. By this time my neck and chest was itching and heavy feeling and I felt my breathing effort was increased mildly. I was given IV decadon and IV pepcid. After about an hour and a half my symptoms slowly resolved. The last symptom to resolve was difficulty swallowing. I was told to continue oral benadryl and or pepcid. I was discharged home after 4 hours under my own care.

Lip swelling with patchy redness but progressed after taking tylenol. Resolved next day at around 5pm.

Within less than 10 minutes after receiving the vaccine, the patient complained of swelling and numb sensation to lips and metallic taste in her mouth. No trouble breathing or swallowing. Seen in emergency room. Given Benadryl 25 mg PO. At 1047 symptoms were all resolved and patient was discharged with instructions to take Benadryl 25 mg every 6 hour as needed. Return to ER if needed.

Approximately 1 1/2 to 2 hours after the shot, my mouth started to feel funny and slightly numb. My heart felt like it was fluttering and I felt weak and tired. I laid down and the symptoms continued with a tingling sensation, especially in my left arm, very slight tightness in my chest, and very cold feeling coursing through my limbs and body. My heart felt like it was racing. The following day I felt weak, like my blood pressure was low though I didn't check it. I was tired, dizzy the following day with frequent fluttering heart feelings. I had a headache for a few days following.

The whites of my eye turned red/ pink. They did not itch or water. They were not as red the next day. Almost completely gone now after 5 days.

Patient reported her throat was scratchy, back of throat tingling, had a little cough. Skin flushed per patient. HCP on site assessed, lungs clear, vital signs stable. 10mg Zyrtec given sublingually. Patient tolerated it well. After 15 minutes, symptoms improved per patient. Vital signs stable. HCP on site reassessed. Lungs clear, airway patent. Heart rate regular rate and rhythm. Patient discharged from clinic.

At 3:10 pm, 10 minutes after vaccine given, patient began experiencing itching and lip tingling. Vital signs were taken patient BP was 220/120, pulse 86 and oxygen sat was 98% on room air. Paramedics was called, patient began experiencing full body itching and became hoarse and began clearing her throat, face became flushed, vitals taken again and BP was 210/120 and O2 was 98 %. Paramedics arrived at 3:18 and IV was started, patient was given 50mg benadryl IV push and transported to hospital

Approximately 45 minutes to an hour after receiving the vaccine she started feeling like she was having throat swelling and difficulty swallowing and swelling on her right upper lip and right face. No difficulty breathing.

Lost control and feeling of my right leg and right arm for approximately three minutes. Started with tingling and then no feeling or control of them. I had blurry vision and was disoriented.

Got very dizzy and cold sweats a few minutes after vaccine. Then I had a seizure and thankfully my husband was there and called the paramedics because he thought I was having a stroke and when they came I was waking up but I had very blurry vision and I was very very sleepy and my memory wasn't very good. The paramedics came and checked my vitals and my blood pressure was very very low but I got to feeling better and stayed there for more time. I was very very tired and my memory was kind of bad for the rest of the day. My husband said I was twitching and my eyes were rolled back when I was seizing and he was a little over a minute when I was seizing.

four minutes post administration- chest tightness @ an 8 (0-10 scale, 10 greatest discomfort/pain) of discomfort, chest and abdomen hives with itchiness. One hour post administration left side throat and ear pain (pain was a 6 )with swelling possibly to lymph node ( lasted 37 hours post administration). Hives and itchiness continued for 43 hours post administration. I did orally take 25 mg of Diphenhydramine 30 minutes prior to administration of the vaccine. Once symptoms begin I was advised to orally take 50mg of Diphenhydramine and wait 30 minutes for further observation. I continued to take my daily medications as directed and Diphenhydramine 25mg as needed for the itchiness and hives.I did inform my primary care provider and allergist of my reaction, both physicians advised me to not have the second dose administered. I followed their directive and I did not have the second dose of Moderna administered in January.

"Moderna COVID-19 vaccine EUA" Four hours after 2nd Moderna vaccine a raised rash appeared on lower right side of face, then to chin, then to left side of lower jaw. Tingling of outer lips. Whole facial swelling. Fast heart beat four hours after that.

Constant pressure headache in front of head, tinnitus and anxiety that still has not resolved 4+ weeks after first shot. Anxiety is similar to GAD/Panic Disorder, which was previously controlled with Zoloft (since discontinued). Vaccine caused resurgence of anxiety/panic. Headache does not respond to any of the following: aspirin, Tylenol, Advil, Aleve or any combination thereof. Neurologist prescribed gabapentin and fioricet. Acupuncture for temporary symptom relief.

4/7/2021-Very sore injection site. 4/8/2021-Repeated rapid trips for bowel movements in AM then hot flashes/fever in PM. 4/9/2021-Mild irritability after work feeling rushed. Trip out of state she vented a lot of stress related events unusually. 4/10/2021-Unusual heightened smelling and cleaning tendency followed by emotional mood swing later at night. She felt like a migraine was coming on. 4/11/2021-She barely slept and cleaned all night then read self-care books outside on porch. Excessively packed the car to head home then repacked in an unusual manner and mood. Took a Ketorolac (Tordol) to try to ease migraine she felt was coming on. Refused to let husband drive home because of drinking a beer. Made it home

7pm started feeling symptoms of fever, chills, eyes burning, but temp was 98.2. By 9pm severe chills, involuntary shaking, teeth chattering, still 98.2. Unable to relax due to chills & shaking. 1am got up & retook temperature currently 100.2. Eyes hurt & red, freezing, and goosebumps. Achy & uncomfortable. Headache. Still continuing.

body contracted again, started in calves and feet and hands, went into neck and face; full body tetany; Left side of face cured up/ left side of my face was drooping, could not smile/ happened again in the ER around 1:15 AM so i was admitted; Terrible headache/ massive headache/ headache around back of head persisted; Ringing in ears; Shortness of breath; Sometimes dizzy; Fatigue; lumbar puncture relieved excess CSF and reduced pressure; Couldn't move left side; elevated BP persisted; Could be a Tetany or dystonic reaction to the vaccine due to timing of everything/ Muscless tightened all over body/ within minutes after vaccination hands/ feet/ legs contracted/ curled up; Could be a Tetany or dystonic reaction to the vaccine due to timing of everything; passed out immediately following vaccine; Blood pressure was still high pulse was high 120/ BP went sky high (196/148)/ BP remained high; Fainted when she got the shot; Hyperventilation syndrome; Whole body hurt/ very sore body; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Left side of face cured up/ left side of my face was drooping, could not smile/ happened again in the ER around 1:15 AM so i was admitted), HEMIPLEGIA (Couldn't move left side), HEADACHE (Terrible headache/ massive headache/ headache around back of head persisted), DYSTONIA (body contracted again, started in calves and feet and hands, went into neck and face), TETANY (full body tetany), HYPERTENSION (elevated BP persisted), DYSTONIA (Could be a Tetany or dystonic reaction to the vaccine due to timing of everything/ Muscless tightened all over body/ within minutes after vaccination hands/ feet/ legs contracted/ curled up), SYNCOPE (Fainted when she got the shot) and LOSS OF CONSCIOUSNESS (passed out immediately following vaccine) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pneumonia on 08-Oct-2020. Concurrent medical conditions included COVID-19 (Positive for COVID; Sick for 5 weeks followed with pneumonia, long COVID-19) since 19-Sep-2020, Fainting (History of Fainting; reported as normal for the patent), Drug allergy, Blood pressure high since 19-Sep-2020, Oxygen saturation decreased (2 L via nasal cannula on night) since 19-Sep-2020, Dizziness since 19-Sep-2020 and Headache since 19-Sep-2020. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Anxiety, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) from 16-Jan-2021 to an unknown date for Attention deficit hyperactivity disorder, CLONAZEPAM for Sleep disorder NOS. On 16-Jan-2021 at 12:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced HEADACHE (Terrible headache/ massive headache/ headache around back of head persisted) (seriousness criterion hospitalization) and PAIN (Whole body hurt/ very sore body). 16-Jan-2021, the patient experienced SYNCOPE (Fainted when she got the shot) (seriousness criterion medically significant) and HYPERVENTILATION (Hyperventilation syndrome). On 16-Jan-2021 at 12:15 PM, the patient experienced LOSS OF CONSCIOUSNESS (passed out immediately following vaccine) (seriousness criterion medically significant) and HYPERTENSION (Blood pressure was still high pulse was high 120/ BP went sky high (196/148)/ BP remained high). On 16-Jan-2021 at 12:30 PM, the patient experienced DYSTONIA (Could be a Tetany or dystonic reaction to the vaccine due to timing of everything/ Muscless tightened all over body/ within minutes after vaccination hands/ feet/ legs contracted/ curled up) (seriousness criterion medically significant). 16-Jan-2021 at 12:30 PM, the patient experienced TETANY (Could be a Tetany or dystonic reaction to the vaccine due to timing of everything). On 17-Jan-2021, the patient experienced FACIAL PARALYSIS (Left side of face cured up/ left side of my face was drooping, could not smile/ happened again in the ER around 1:15 AM so i was admitted) (seriousness criterion hospitalization), HEMIPLEGIA (Couldn't move left side) (seriousness criterion hospitalization) and HYPERTENSION (elevated BP persisted) (seriousness criterion hospitalization). On 17-Jan-2021 at 7:00 PM, the patient experienced DYSTONIA (body contracted again, started in calves and feet and hands, went into neck and face) (seriousness criterion hospitalization) and TETANY (full body tetany) (seriousness criterion hospitalization). On 05-Feb-2021, the patient experienced LUMBAR PUNCTURE (lumbar puncture relieved excess CSF and reduced pressure). On an unknown date, the patient experienced TINNITUS (Ringing in ears), DYSPNOEA (Shortness of breath), DIZZINESS (Sometimes dizzy) and FATIGUE (Fatigue). The patient was hospitalized from 17-Jan-2021 to 18-Jan-2021 due to DYSTONIA, FACIAL PARALYSIS, HEADACHE, HYPERTENSION and TETANY, and then on 17-Jan-2021 due to HEMIPLEGIA. On 16-Jan-2021, DYSTONIA (Could be a Tetany or dystonic reaction to the vaccine due to timing of everything/ Muscless tightened all over body/ within minutes after vaccination hands/ feet/ legs contracted/ curled up), LOSS OF CONSCIOUSNESS (passed out immediately following vaccine) and TETANY (Could be a Tetany or dystonic reaction to the vaccine due to timing of everything) had resolved. On 18-Jan-2021, FACIAL PARALYSIS (Left side of face cured up/ left side of my face was drooping, could not smile/ happened again in the ER around 1:15 AM so i was admitted), DYSTONIA (body contracted again, started in calves and feet and hands, went into neck and face), TETANY (full body tetany) and HYPERTENSION (elevated BP persisted) had resolved. On 05-Feb-2021, HEADACHE (Terrible headache/ massive headache/ headache around back of head persisted) and LUMBAR PUNCTURE (lumbar puncture relieved excess CSF and reduced pressure) had resolved. At the time of the report, HEMIPLEGIA (Couldn't move left side), SYNCOPE (Fainted when she got the shot), TINNITUS (Ringing in ears), HYPERVENTILATION (Hyperventilation syndrome) and PAIN (Whole body hurt/ very sore body) outcome was unknown, HYPERTENSION (Blood pressure was still high pulse was high 120/ BP went sky high (196/148)/ BP remained high) had resolved and DYSPNOEA (Shortness of breath), DIZZINESS (Sometimes dizzy) and FATIGUE (Fatigue) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Blood pressure measurement: 196/148 High. On 16-Jan-2021, Blood test: normal normal. On 16-Jan-2021, Heart rate: 120 High. On 16-Jan-2021, Magnetic resonance imaging: normal normal. On 17-Jan-2021, Blood pressure measurement: 190/140 High. On 17-Jan-2021, Computerised tomogram: ruled out stroke normal. On an unknown date, Blood pressure measurement: 192/144 High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered FACIAL PARALYSIS (Left side of face cured up/ left side of my face was drooping, could not smile/ happened again in the ER around 1:15 AM so i was admitted), HEADACHE (Terrible headache/ massive headache/ headache around back of head persisted), DYSTONIA (body contracted again, started in calves and feet and hands, went into neck and face), TETANY (full body tetany), HYPERTENSION (elevated BP persisted), DYSTONIA (Could be a Tetany or dystonic reaction to the vaccine due to timing of everything/ Muscless tightened all over body/ within minutes after vaccination hands/ feet/ legs contracted/ curled up), LOSS OF CONSCIOUSNESS (passed out immediately following vaccine), HYPERTENSION (Blood pressure was still high pulse was high 120/ BP went sky high (196/148)/ BP remained high), TETANY (Could be a Tetany or dystonic reaction to the vaccine due to timing of everything), PAIN (Whole body hurt/ very sore body) and LUMBAR PUNCTURE (lumbar puncture relieved excess CSF and reduced pressure) to be possibly related. No further causality assessments were provided for HEMIPLEGIA (Couldn't move left side), SYNCOPE (Fainted when she got the shot), TINNITUS (Ringing in ears), HYPERVENTILATION (Hyperventilation syndrome), DYSPNOEA (Shortness of breath), DIZZINESS (Sometimes dizzy) and FATIGUE (Fatigue). Treatment medication included: Injections of Benadryl and IV Benadryl en route to hospital, Ibuprofen daily as needed and a shot of Toradol. Case Comment/Sender's Comment - This case concerns a 44 year old, female patient, with history of fainting, COVID-19 (September 2020), who experienced a serious unexpected event of syncope, hemiplegia, facial paralysis and dystonia among others, 2 day after receiving 1st dose of mRNA- 1273 (Lot# Unknown). Very limited information regarding this event has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Updated patient medical history, concomitant medications, treatment medication, new events, outcome and causality.; Reporter's Comments: This case concerns a 44 year old, female patient, with history of fainting, COVID-19 (September 2020), who experienced a serious unexpected event of syncope, hemiplegia, facial paralysis and dystonia among others, 2 day after receiving 1st dose of mRNA- 1273 (Lot# Unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.

After my first dose, I felt an occasional fullness in my right ear. After the second dose, on the date above, I began hearing my heartbeat pulsing in the same ear. It has continued periodically for brief amounts of time. I am more sensitive to high-pitched sounds and feeling of fullness continues. Doctor said ears looked perfect the day after onset. Prescribed Claritin D and made a referral to ENT.

Fainted; Concussion; Dizziness / Light-headed; Vertigo; Loss of taste; Lost sense of smell; Soreness in the arm; This spontaneous case was reported by a physician assistant and describes the occurrence of SYNCOPE (Fainted) and CONCUSSION (Concussion) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Thyroid activity decreased and Allergy (Undefined allergies). Concomitant products included CLARITHROMYCIN (CLARITRON) for Allergy, THYROID for Thyroid activity decreased. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm). On 17-Apr-2021, the patient experienced VERTIGO CNS ORIGIN (Vertigo), AGEUSIA (Loss of taste) and ANOSMIA (Lost sense of smell). On 18-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), CONCUSSION (Concussion) (seriousness criterion medically significant) and DIZZINESS (Dizziness / Light-headed). On 18-Apr-2021, SYNCOPE (Fainted) had resolved. At the time of the report, CONCUSSION (Concussion), AGEUSIA (Loss of taste) and ANOSMIA (Lost sense of smell) outcome was unknown and DIZZINESS (Dizziness / Light-headed), PAIN IN EXTREMITY (Soreness in the arm) and VERTIGO CNS ORIGIN (Vertigo) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient received her first dose of the Moderna COVID-19 vaccine on Friday (16-Apr-2021) morning in the left arm and had very minimal symptoms, just soreness in the arm. On Saturday evening, she experienced dizziness, was light-headed and fainted She had a concussion because she fell on the floor in her home. She is currently experiencing vertigo and still feels dizzy and light-headed, probably as a result of the concussion. She lost her sense of taste and smell more than likely as a consequence of the concussion. Her arm is still a little bit sore. Treatment for the events: Tylenol (acetaminophen) and Benadryl (diphenhydramine) to sleep at night. company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

little bumps all over her face and body which are like measles; swollen eyes; watery eyes; Runny nose; Sneezing; Congestion on her chest; Dry eye socket; dry eye socket with crust on eyelashes; Headache; allergic reaction for a week/allergic reactions keep coming back; Ear feels full; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of PULMONARY CONGESTION (Congestion on her chest) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Food allergy. Concomitant products included LIRAGLUTIDE (VICTOZA), INSULIN GLARGINE (LANTUS), VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and LOSARTAN for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced EAR DISCOMFORT (Ear feels full). On 21-Apr-2021, the patient experienced HYPERSENSITIVITY (allergic reaction for a week/allergic reactions keep coming back). On an unknown date, the patient experienced PULMONARY CONGESTION (Congestion on her chest) (seriousness criterion medically significant), RASH PAPULAR (little bumps all over her face and body which are like measles), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), DRY EYE (Dry eye socket), BLEPHARITIS (dry eye socket with crust on eyelashes) and HEADACHE (Headache). At the time of the report, PULMONARY CONGESTION (Congestion on her chest), HYPERSENSITIVITY (allergic reaction for a week/allergic reactions keep coming back), RASH PAPULAR (little bumps all over her face and body which are like measles), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), EAR DISCOMFORT (Ear feels full), DRY EYE (Dry eye socket), BLEPHARITIS (dry eye socket with crust on eyelashes) and HEADACHE (Headache) had not resolved. Treatments provided were 25mg diphenhydramine, 16mg Hydrocortisone cream, Metoprolol steroid, and Doxycycline for 7 days given by her HCP. Action taken with mRNA in respect to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events. However, the patient's past medical history of food allergies remains a risk factor for these events. This case was linked to MOD-2021-095202 (Patient Link); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events. However, the patient's past medical history of food allergies remains a risk factor for these events.

congestion on her chest; having allergic reaction for a week.allergic reactions keep coming back; little bumps all over her face and body which are like measles after the vaccine; swollen eyes; watery eyes; runny nose; sneezing; ear feels full; dry eye socket with crust on eyelashes; Crust on eyelashes; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (congestion on her chest) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Food allergy since an unknown date. Concomitant products included LIRAGLUTIDE, INSULIN GLARGINE (LANTUS), VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and LOSARTAN for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced PULMONARY CONGESTION (congestion on her chest) (seriousness criterion medically significant), HYPERSENSITIVITY (having allergic reaction for a week.allergic reactions keep coming back), RASH PAPULAR (little bumps all over her face and body which are like measles after the vaccine), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (runny nose), SNEEZING (sneezing), EAR DISCOMFORT (ear feels full), DRY EYE (dry eye socket with crust on eyelashes), EYELID MARGIN CRUSTING (Crust on eyelashes) and HEADACHE (Headache). At the time of the report, PULMONARY CONGESTION (congestion on her chest), HYPERSENSITIVITY (having allergic reaction for a week.allergic reactions keep coming back), RASH PAPULAR (little bumps all over her face and body which are like measles after the vaccine), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (runny nose), SNEEZING (sneezing), EAR DISCOMFORT (ear feels full), DRY EYE (dry eye socket with crust on eyelashes), EYELID MARGIN CRUSTING (Crust on eyelashes) and HEADACHE (Headache) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Treatment medications Provided were 25 mg Benadryl. 16 mg hydrocortisone cream. metoprolol steroid, and Doxycycline for 7 days given by her HCP. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-095089 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Day 1: within 30 min - severe sharp temporal headache (worst of my life); developed within a couple hours in this sequence: cold hands/feet, chills (no fever), much worsened vision, slight confusion/dizziness, weakness (had to lay down), both knee joint pain, swollen neck glands, moderate nausea and intestinal cramps, complete loss of smell/taste; all night - severe acidic stomach pain (barely relieved with anti-acids). Day 2: residual headache (50%), tiredness, weakness, sweating if doing things, residual knee joint pain, sense of smell/taste returned and heightened. Day 3: residual headache (25%), still not 100%, residual knee joint pain. Day 4 (today): residual knee joint pain (comes and goes). I realize that these are not symptoms of an allergic reaction, but severe side effects.

Patient received vaccine at 11:04. At 11:08 patient was checked on during rounds of monitoring for s/s of reaction and she stated that her hr feels like it was elevated, lips were tingling and the lower right part of her face was numb. Vitals were taken at this time BP was 110/68 HR 102. Patient was given Benadryl 50mg IM at this time x1 and monitored for 10 more minutes. Husband came and picked the patient up due to we told her she was unable to drive.

Patient began feeling symptoms of tongue and hand tingling and throat tightening 5 minutes after receiving her dose. Her vitals were taken and were stable. After 5 more minutes her hands stopped tingling and within 15 minutes her throat symptoms resolved. She continued to have tongue tingling without any facial or tongue swelling. After 25 minutes a physician was contacted and cetirizine 10mg was administered. 25 minutes later her symptoms were resolved and her vitals are stable. She was allowed to go home after that time and was advised to follow up to her PCP.

Pouring sweat, hives, light headedness and dizziness and tremors, weakness, burning, itching of all skin, blurred vision

Approximately 11 minutes after receiving vaccine, patient began experiencing partial numbness to the tip of the tongue. BP 212/126 HR 97 O2=98% @12:00pm. Patient reports that the numbness is subsiding. BP 171/112 HR 86 O2=99% @12:18pm. Patient clinically stable. Patient released from clinic at 12:25pm.

initially started with body aches at 11:00 am on 1/4/2021 and then developed a fever and chills at 4:00 and 5:00 severe body aches with difficulty moving/walking due to pain and also had slight sore throat - best description is I felt like I had been hit by a truck. Napped from 5-6:30 and then to bed at 10:00. Woke up on 1/5/2021 without body aches but continued with slight ichy throat and feeling like the roof of mouth and tongue were burnt. Continuing to feel those symptoms on 1/6/2021

Noticed a mild headache and fatigue before going to bed for the night, about 8 pm on 1/4/21. My jaw on the left felt sore. I took 2 Aleve. Upon waking the next day(1/5/21) , I felt like I had a migraine on the left side of my face. Head, ear, and jaw on the left side was painful. Used Aleve . The pain was still present, although a little less intense the following day (1/6/21). Arm is also sore but much more manageable than the head pain.

Reaction- nausea/vomiting, flushing, lips tingling, dry mouth, lightheaded (not dizzy though)- onset of symptoms approx. 12 min post injection, temp elevation in ER ER about 1 hr- given ODT Zofran, IM Benadryl and Solumedrol

Patient received the vaccine in her arm. Then at the 12 min mark, she felt her lips tingling, dry mouth, light headed, flushed, and nauseated. She was taken to the Emergency Dept where she was given a Zofran and still vomited once. Then she got a Benadryl and Solumedrol injections. Then she was observed for an hour and a half. Her temp did go up to 99.2 from around 98.4. HR 90-100s. O2 sats normal.

For the first few days: sore arm but was otherwise fine. About a week later, noted itching, redness, and swelling around the injection site. A couple days after that, developed general itchiness and some eye irritation; no rash or fever. Symptoms improving with antihistamine.

Patient received vaccine on Jan. 5, 2021 at one o'clock and symptoms began when she got home at 5:30 pm. She experienced headache, nausea, vomiting, chills, night sweats, sore arm, dry mouth, mild fever 99.7 was the highest recorded temperature. Patient called our employee hotline and was told to have a Covid test seeing as the symptoms were the same. She tested negative and began to feel better by the third day with residual symptoms of nausea and fatigue.

approximately 15 minutes after the vaccine was administered I developed numbness in my tongue, metallic taste in mouth, and headache and a fullness feeling in ears. 1 and 1/2 hours later I developed neck pain and numbness in the left side of my face that lasted for 48 hours. Benadryl was taking for 2 days to help with the reaction. Day 3 after the vaccine symptoms seemed to resolve except for a slight feeling of numbness in left cheek but much better than first 2 days and almost gone completely.

Metallic taste in her mouth, swollen lips and cheeks, slight difficulty breathing, thought to be d/t anxiety Narrative: Employee reported anaphylactic reaction to previous vaccination but apparently denied this in ED. Has allergy to penicillin, receives weekly iron infusions. Given Benadryl and sent home in stable condition.

Dizziness, Headache, Arthralgia, chest tightness, sensation of throat swelling, subjective fever, dry mouth, anxiety Narrative:

Headache NASAL DRAINAGE, HEADACHE, FLUSHING, CHILLS, FATIGUE Narrative: ABOUT 30 MIN. AFTER VACCINATION, PATIENT BEGAN TO FEEL OFF-BALANCED WITH A MILD HEADACHE ABOVE THE RIGHT EYE. FOREHEAD WAS FLUSHED, WATERY EYES, RUNNY NOSE, FATIGUE AND CHILLS. LEFT UPPER ARM IS SORE, MORE NOTICEABLE WITH MOVEMENT. AT TIME OF REPORT, PATIENT CONTINUES TO HAVE RIGHT SIDED HEADACHE, SORE UPPER ARM, CHILLS AND FATIGUE.

LIPS SWELLED UP AFTER 35 MIN , NEXT MORNING HEADACHE , BODY ACE AND ARM VERY SORE , LIPS STILL SWOLLEN BUT NOT AS MUCH

Patient stated she was experiencing blurry vision, nausea and dizziness approximately 10minutes post vaccination. Vitals were stable BP 137/87 P. 72 Sp02 99% Patient was provided cold compress and monitored for an additional 20minutes. Patient's s/s resolved. Patient stable.

short of breath, dry cough, runny nose, dry throat, sore arm where injection was, swollen arm, slight dizziness.

dry mouth/ metal taste/ excessive thirst, extreme dry eyes to the the point of burning/ gritty sensation (used multiple doses of natural tears to treat)

Anxious, mouth numb, cough - asked for inhaler, 25 mg po bendaryl given. Tongue becomes numb. Difficulty breathing. Called ambulance.

About 15 min ?icy hot? numb feeling hands feet, lips mouth, dizzy, difficulty thinking, heart pounding, tongue felt big, nausea, tightness back throat that progressed down neck, paramedics reported near syncope decreased pupil& verbal response, tachycardia, red neck chest, spots on face. On site ambulance IV meds Epi? Benadryl 50mg and o2, transferred to ER- IV meds Pepcid and solumedrol, and home 5 days oral prednisone, Benadryl, Pepcid, albuterol

20 min post vaccination (conducted in workplace setting), patient report feeling of swelling of tongue; in her words "thick feeling tongue." Also reported L upper chest tenderness and "very tired and no energy." RN found no SOB, not appearance of swollen tongue or other angioedema, no evidence of urticaria, no respiratory distress including no wheezing. Not evidence of vasovagal response. After consultation, RN provided 12.5 mg Benadryl IM in opposite arm of vaccination. Pt remained under observation of RN and after 30 min states she feels better, previous symptoms abated, and again without evidence of anaphylaxis. Pt was released back to office 45 min after first presenting with symptoms. Pt stated "I think I was anxious." on departure.

08:50AM Upon standing to leave pt stated she was lightheaded & dizzy. Instructed to sit. BP: 126/80, SO2 RA 96%, HR:80x' Pt stated she was nervous when getting the vaccine. 09:05AM Still "feeling off, blurred vision." 09:10AM SO2 RA: 100%, HR: 82 Drinking water. Denies SOB 09:30AM feeling better. Encouraged not to drive. A friend here that will take pt. home. Pt advised to F/U with her PCP 10:03AM Pt discharged

Seven days exactly after receiving the dose, skin on neck broke out in rash. Approximately, 8 hours later, the rash increased area and redness. One percent cortisone was applied. The next day, raised plaques developed, itchiness, and more redness. Zantac and one benedryl were taken with no relief the next morning. The rash was popping up on the facial skin with little bumps. Benedryl topical cream was applied to neck which decreased the rash on the neck. Claritan was taken at night. The next morning, the face was affected with rash and bumps, the eyes were swollen, red, and itchy. the lips were swollen and burning around the lip line, the tongue was slightly swollen and canker sore on the right side of the tongue. The patient went to employee health for eval. The NP ordered the patient to go to the ED to seek medical attention.

metal taste in mouth 30 min after injection received, itching sensation on left arm 1 hour after injection received. Pt. evaluated by their in house medical team who administered a Benadryl injection to the right arm, unknown dosage. The pt. told me the nurse on staff measured her SPO2 at 86% and wanted to call 911 for transport to the ER. Pt. reports she refused and left work to come to the urgent care clinic where I evaluated her. She is concerned that she could be having a panic attack vs. allergic reaction. Her itching arm and metallic taste has resolved but she feels chest pains on the left side of her chest and her left arm feels heavy.

RN was the vaccinator at the time and immediately after administration patient complained of feeling light headed. Patient reported not having eaten prior to vaccination. Patient given Gatorade and crackers. At 11:40am patient complained of feeling tingling in her tongue, difficulty breathing, and difficulty swallowing. RN administered epi- pen at 11:41 am. 02 sat 99, BP 140/90, HR 80. Patient given therapeutic 02. Patient reported feeling improved. Patient transported via EMS to ED.

+35 min post injection, Tightness/closing throat only, difficulty swallowing, tachycardia, runny nose, marked increase in paresthesia body wide (pin pricks), itching body wide, feeling of swollen tongue but not visualized. Tx w/ diphenhydramine. 100mg liquid prn symptoms (2 doses 5 hrs apart). Diphenhydramine reduced symptoms but tightness in throat sensation, paraesthesia, and mild itching remained w/ sudden shorts bursts of increased symptoms. No antihistamines administered after second dose and most symptoms subsided, except increased paresthesia and ?fuzzy? tongue/throat. Appx 1530 on 01/17/21, sore throat arose that is uncomfortable but not serious, tongue tingling.

About 7 minutes after injection I experienced: Dizziness and weakness Accelerated heartbeat Fast pulse Gummy throat Chills and shaking Body numbness or feeling body was in slow motion Four nurses came to my side and took blood pressure which was unusually high. Also took pulse which was racing. Offered water and I was able to drink it. They monitored me for approximately 40 minutes as symptoms slowly receded. I was advised not to drive home, to take it easy the rest of the day and to go to emergency room if any other symptoms occurred. Mild dizziness continued for a bit in the afternoon and all symptoms subsided by the evening hours.

On the fourth day I developed intractable nausea and vomiting associated with tinnitus, vertigo and imbalance.

Numbness to the lips, nose, left and right cheeks. Presented 15 minutes after vaccine. Paramedic on site monitored blood pressure and heart rate. Numbness was minimal after 30 minutes and completely gone after 1 hour

Vomiting 12 hours post vaccine. 24 hours post vaccine temps 104+ to 106.8 temp orally 30 hours post vaccine. Red swollen eyes 24 hours post vaccine. Ringing in ears and temporary loss of hearing comes and goes.